Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer (NCT03301350) | Clinical Trial Compass
CompletedPhase 2
Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer
United States29 participantsStarted 2017-11-07
Plain-language summary
This is a phase II single-arm, open-label, prospective study to evaluate the efficacy of the low dose weekly Carboplatin/Paclitaxel followed by dose-dense Doxorubicin/Cyclophosphamide in subjects with triple-negative breast cancer in neoadjuvant settings.
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion criteria
✓. Subjects must have histologically or cytologically confirmed invasive breast cancer which meets the following criteria:
✓. Estrogen Receptor (ER) and Progesterone Receptor (PR)-negative as defined by local standard clinical immunohistochemistry (IHC) \< 1%.
✓. HER2-negative using local standard testing. Negative is defined as IHC 0 or 1+ (if 2+, must reflex to ISH method). If ISH method is used, ratio \< 2 is considered negative.
✓. Clinical tumor size of at least 2.1 cm (T2) by palpation or imaging, regardless of the ipsilateral regional lymph node status, or any tumor size but with ipsilateral regional lymph nodes involved by the tumor (any T if ipsilateral regional node positive). Subjects with inflammatory breast cancer are eligible. If bilateral breast cancer is present, the subject is eligible if the contralateral tumor is DCIS only (without any invasive disease on biopsy) or another invasive breast cancer of any size that is also ER, PR and HER2 negative.
✓. Any radiographic abnormal ipsilateral regional lymph nodes or any clinically concerning ipsilateral regional lymph nodes with the exception of internal mammary nodes should be sampled with percutaneous biopsy, but no sentinel axillary lymph node mapping/biopsy is allowed before chemotherapy. If clinically node negative (cNO), pre-chemotherapy ipsilateral sentinel axillary lymph node mapping/biopsy is not allowed.
✓. Candidate for neoadjuvant chemotherapy.
✓. Age \> 18 years and \< 75 years
✓. ECOG Performance Status \< 1.
Exclusion criteria
✕
What they're measuring
1
Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate
. Prior chemotherapy or radiation therapy for invasive breast cancer within 6 months before registration.
✕. Prior investigational drugs or interventions for invasive breast cancer within 6 months before registration are not allowed. Prior participation in window-of-opportunity trials without therapeutic intent is allowed if intervention is no more than 3 weeks duration.
✕. Stage IV metastatic breast cancer
✕. History of allergic reactions attributed to compounds of similar chemical composition to chemotherapy to be used in this study.
✕. Breastfeeding women. Cytotoxic chemotherapy is drug with the potential for teratogenic or abortifacient effects. Due to unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cytotoxic chemotherapy, breastfeeding should be discontinued.
✕. Baseline peripheral neuropathy of severity \> grade 1
✕. Other invasive cancer diagnosis within the past 5 years other than non-melanoma skin cancer.
✕. Prior axillary lymph node dissection that preclude patient from surgical evaluation of axillary lymph node status.