At a glance
ClinicalIndex Comparison Record- ✓Female patients age ≥18 years
- ✓Cohort A: Clinical Stage IIIA, IIIB, or IIIC breast cancer with mass ≥2.0 cm by clinical exam (or inflammatory BC without measurable disease requirement)
- ✓Cohort B: Pathologically confirmed pN2 or pN3 nodal status after mastectomy or lumpectomy with adequate margins; surgery within 84 days of study entry
- ✓Invasive adenocarcinoma diagnosed by core needle or limited incisional biopsy (Cohort A)
- ✕Metastatic disease (clinical or radiologic evidence)
- ✕Synchronous bilateral invasive breast cancer
- ✕History of ipsilateral or contralateral invasive breast cancer (or ipsilateral DCIS treated with RT)
- ✕Non-breast malignancy within 5 years (except carcinoma in situ of cervix/colon, melanoma in situ, basal/squamous cell skin cancer)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Clinical Trial of Epirubicin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Bevacizumab Given as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or Given as Adjuvant Therapy for HER2-Positive Pathologic Stage III Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Epirubicin, Cyclophosphamide, and 3 other interventions for Breast Cancer. Completed, enrolled 105 participants across 36 sites in 2 countries.
Detailed Summary
The main purpose is to learn if adding bevacizumab to standard chemotherapy and trastuzumab to treat HER2-positive breast cancer will affect heart function. This study will evaluate: * How bevacizumab, given with chemotherapy, and then bevacizumab given with trastuzumab after surgery, will affect breast tumors * Side effects from adding bevacizumab to chemotherapy and trastuzumab * Whether adding bevacizumab to chemotherapy and trastuzumab for breast cancer will affect the heart * If receiving bevacizumab will have any effect on how patients recover from surgery
Study Details
Timeline
Interventions
Both Cohorts: Epirubicin 90 mg/m2 IV every 21 days x 4 cycles
Both Cohorts: Cyclophosphamide 600 mg/m2 IV every 21 days x 4 cycles
Both Cohorts: Docetaxel 100 mg/m2 IV on Day 1 every 21 days x 4 cycles
Cohort A: Pre-op therapy - 4 mg/kg IV first dose, then subsequent doses at 2 mg/kg IV weekly (16+ weeks) until 1-7 days prior to surgery. Post-operative therapy (beginning no sooner than 28 days after surgery and continuing every 3 weeks x 13 doses) - 8 mg/kg IV first post-op dose, then subsequent doses at 6 mg/kg IV Cohort B: 4 mg/kg IV first dose, then subsequent doses at 2 mg/kg IV weekly on days 1, 8, and 15. Three (3) weeks after last dose of docetaxel, 6 mg/kg IV and continuing every 3 weeks x 13 doses
Cohort A: Cycles 1-4, 15 mg/kg IV on day 1 of cycle 4 only; Cycles 5-7, 15 mg/kg IV on day 1 every 21 days x 3 cycles; post-operative therapy (beginning no sooner than 28 days after surgery), 15 mg/kg IV every 3 weeks x 13 doses Cohort B: Cycles 5-8, 15 mg/kg IV on day 1 every 21 days x 4 cycles; beginning 3 weeks after last dose of docetaxel, 15 mg/kg IV every 3 weeks x 13 doses