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1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Confusional state 1/32 (3.13%) secondary trial: Cardiac failure congestive 1/752 (0.13%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Confusional state 1/32 (3.13%) secondary trial: Left ventricular dysfunction 0/752 (0.00%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Confusional state 1/32 (3.13%) secondary trial: Total: 117/382 (30.63%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Confusional state 1/32 (3.13%) secondary trial: Anaemia 3/382 (0.79%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Confusional state 1/32 (3.13%) secondary trial: Disseminated intravascular coagulation 0/382 (0.00%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Confusional state 1/32 (3.13%) secondary trial: Febrile neutropenia 11/382 (2.88%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Confusional state 1/32 (3.13%) secondary trial: Neutropenia 20/382 (5.24%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Confusional state 1/32 (3.13%) secondary trial: Thrombocytopenia 0/382 (0.00%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Confusional state 1/32 (3.13%) secondary trial: Atrial fibrillation 1/382 (0.26%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Confusional state 1/32 (3.13%) secondary trial: Atrial flutter 1/382 (0.26%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Confusional state 1/32 (3.13%) secondary trial: Cardiac failure congestive 0/382 (0.00%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Confusional state 1/32 (3.13%) secondary trial: Left ventricular dysfunction 1/382 (0.26%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients with histologic confirmation of invasive breast carcinoma. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients must have intact primary tumor. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients greater than or equal to 18 years. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients should have T1N1-3M0 or T2-4 N0-3M0. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients with bilateral breast cancer are eligible. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients with second primary breast cancers are eligible. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients should have a Karnofsky performance scale of greater than or equal to 70%. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients must have clinically measurable disease to be treated in the neoadjuvant setting. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of greater than or equal to 1500/mm^3, and platelet count greater than or equal to 100000mm^3. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients must have adequate liver function with a bilirubin within normal laboratory values. Alkaline phosphatase and transaminases (ALT and AST) may be up to 1.5 x upper limit of normal (ULN) of the institution. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible ...
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients should have adequate renal function with creatinine levels within normal range. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients should have a normal left ventricular ejection fraction (LVEF) of greater than or equal to 50%. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Negative serum or urine pregnancy test for a woman of childbearing potential (WOCBP). Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
WOCBP must use a reliable and appropriate contraceptive method during the study and six months after chemotherapy is completed. WOCBP are women who are not menopausal for 12 months or had no previous surgical sterilization. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) ar...
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients must agree to have study biopsies. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Her2Neu, ER and PR positive patients should be excluded. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients with Inflammatory breast cancer (IBC) are excluded. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients with an organ allograft or other history of immune compromise. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Prior treatment with any investigational drug within the preceding 4 weeks. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Chronic treatment with systemic steroids or another immunosuppressive agent. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
A Known history of HIV seropositivity. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin defined as 1 mg a day). Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Other concurrent and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias, activ...
0
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Patients with a pre-existing peripheral neuropathy. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: Laser Therapy Alone secondary trial: Part A Abemaciclib: HR+, HER2+ Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: Laser Therapy Alone secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent t...
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: Laser Therapy Alone secondary trial: Part B Abemaciclib: HR+, HER2- Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: Laser Therapy Alone secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Laser Therapy is in each cohort of the primary trial and the secondary trial, along wit...
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: Laser Therapy Alone secondary trial: Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: therapist administered laser treatment secondary trial: Part A Abemaciclib: HR+, HER2+ Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: therapist administered laser treatment secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer rec...
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: therapist administered laser treatment secondary trial: Part B Abemaciclib: HR+, HER2- Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: therapist administered laser treatment secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Laser Therapy is in each cohort of the primary trial and the seconda...
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: therapist administered laser treatment secondary trial: Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: laser: therapist administered laser secondary trial: Part A Abemaciclib: HR+, HER2+ Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: laser: therapist administered laser secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiv...
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: laser: therapist administered laser secondary trial: Part B Abemaciclib: HR+, HER2- Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: laser: therapist administered laser secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Laser Therapy is in each cohort of the primary trial and the secondary ...
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: laser: therapist administered laser secondary trial: Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: Mld Alone secondary trial: Part A Abemaciclib: HR+, HER2+ Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: Mld Alone secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab...
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: Mld Alone secondary trial: Part B Abemaciclib: HR+, HER2- Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: Mld Alone secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuv...
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: Mld Alone secondary trial: Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: therapist administered manual lymphatic drainage secondary trial: Part A Abemaciclib: HR+, HER2+ Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: therapist administered manual lymphatic drainage secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast ...
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: therapist administered manual lymphatic drainage secondary trial: Part B Abemaciclib: HR+, HER2- Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: therapist administered manual lymphatic drainage secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Laser Therapy is in each cohort of the primary trial and t...
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: therapist administered manual lymphatic drainage secondary trial: Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: manual lymphatic drainage: therapist administered massage therapy secondary trial: Part A Abemaciclib: HR+, HER2+ Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: manual lymphatic drainage: therapist administered massage therapy secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive H...
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: manual lymphatic drainage: therapist administered massage therapy secondary trial: Part B Abemaciclib: HR+, HER2- Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: manual lymphatic drainage: therapist administered massage therapy secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Laser Therapy is in each cohort of the pr...
0
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
primary trial: manual lymphatic drainage: therapist administered massage therapy secondary trial: Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participat...
0
96b77cdd-aa9f-4770-8447-8a04d9ca5da7
Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial.
0
96b77cdd-aa9f-4770-8447-8a04d9ca5da7
Diagnosis may be made by fine needle aspiration cytology or core biopsy Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial.
0
96b77cdd-aa9f-4770-8447-8a04d9ca5da7
A repeat core biopsy is not required for patients who have a paraffin embedded diagnostic core biopsy specimen available for immunohistochemical staining Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial.
0
96b77cdd-aa9f-4770-8447-8a04d9ca5da7
Patients with locally advanced disease who are planning to undergo preoperative neoadjuvant therapy are not eligible* Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial.
0
96b77cdd-aa9f-4770-8447-8a04d9ca5da7
Locally advanced disease includes any of the following: Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial.
0
96b77cdd-aa9f-4770-8447-8a04d9ca5da7
Primary tumor 5 cm (T3) Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial.
0
96b77cdd-aa9f-4770-8447-8a04d9ca5da7
Tumor of any size with direct extension to the chest wall or skin (T4a-c) Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial.
0
96b77cdd-aa9f-4770-8447-8a04d9ca5da7
Inflammatory breast cancer (T4d) Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial.
0
96b77cdd-aa9f-4770-8447-8a04d9ca5da7
Fixed axillary lymph node metastases (N2) Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial.
0