At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed breast adenocarcinoma with tissue available for ER/PR/HER2 testing (needle or incisional biopsy only; excisional not permitted)
- ✓Resectable clinical stage I (T≥2.0 cm), IIA-IIIA, or unresectable stage IIIB-C disease with no evidence of M1 disease
- ✓Breast tumor ≥1 cm by ultrasound/MRI, or if no measurable breast disease, measurable axillary node ≥1 cm with confirmed metastatic disease
- ✓HER2+ by IHC 3+ or FISH amplification (ratio >2.0 or ≥6 HER2 targets per cell); equivocal cases (IHC 2+ with FISH ratio <2.0) excluded
- ✕Prior chemotherapy, hormonal therapy, or radiation therapy for this cancer
- ✕Congestive heart failure, unstable angina, uncontrolled arrhythmia ≥grade II, or significant peripheral vascular disease; BP >180 systolic or >100 diastolic absolute contraindication
- ✕Myocardial infarction, stroke, or arterial thrombotic event within past 12 months
- ✕Pregnant or lactating women
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy of Carboplatin and Paclitaxel With Trastuzumab and Pertuzumab (wPCbTP) and Switching to an Anthracycline-based Regimen (AC) in Non-responding Patients in Clinical Stage I-III HER2-positive Breast Cancer.
In Brief
A Phase 2 clinical trial evaluating paclitaxel, Trastuzumab, and 4 other interventions for Breast Cancer. Completed, enrolled 32 participants across 2 sites.
Detailed Summary
Neoadjuvant therapy is given to breast cancer patients whose cancers are relatively large or have spread to lymph nodes or both. The primary goal of this treatment is to prevent the cancer from coming back (recurring) elsewhere in the body, but if it makes the cancer in the breast and lymph nodes shrink it might be easier to remove. This could allow a patient to have a lumpectomy instead of a mastectomy and reduce the number of lymph nodes that the surgeon has to remove. In some cases, the neoadjuvant therapy works so well that it kills all of the cancer in the breast and lymph nodes. This is referred to as a pathologic complete response (pCR). Patients who achieve a pCR have a much lower risk of the cancer recurring elsewhere in their bodies. Investigators aren't sure which chemotherapy drugs work best with the HER2-targeted drugs, and what combination of these drugs causes the fewest side effects.Thus, this study has two main goals: 1. To find out if treatment with wPCbTP, weekly paclitaxel and carboplatin given with trastuzumab and pertuzumab every 3 weeks, leads to as many pCRs as TCHP in patients with HER2-positive breast cancer, but has fewer side effects. 2. To find out if HER2-positive patients whose cancers are not responding well after 12 weeks of wPCbTP get a better response when they are switched to a doxorubicin-containing regimen called AC for 4 cycles (8-12 weeks).
Study Details
Timeline
Interventions
80 mg/m2 (or nab-paclitaxel 80-100 mg/m2) weekly
Either every 3 weeks (8 mg/kg cycle 1 then 6 mg/kg cycles 2-4) or weekly (4 mg/kg week 1 then 2 mg/kg weeks 2-12)
every 3 weeks (840 mg cycle 1 then 420 mg cycles 2-4) or weeks 1 and 2 cycle 1 (420 mg each dose) during the first 3-6 weeks of treatment, then 420 mg day 1 of cycles 2-4.
AUC 2 administered weekly with no planned treatment breaks
breast conserving or mastectomy
doxorubicin and cyclophosphamide (AC) every 2 or 3 weeks for 4 cycles Dose-dense AC: Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 IV day 1 every 2 weeks x 4 cycles Standard AC: Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 IV day 1 r every 3 weeks x 4 cycles