NCI Community Oncology Research Program - Protocol Summary
ECOG-ACRIN EA1131 - "A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Breast Clinical Trial
CANCER TYPE: Stage II
RESEARCH BASE: ECOG-ACRIN
NCT NUMBER: NCT02445391
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UPDATED ON 02/22/2019 (19:46:19)
Adjuvant, stage II or III, post operative and neoadjuvant chemo, residual triple negative breast ca, platinum based chemo vs capecitabine. DCP-001 Eligible.
The following materials must be submitted within 21 weeks post surgery: FFPE tumor tissue block ( 1 cm in diameter, > minimal cellularity as per local pathologist determination) from the residual disease on the definitive surgical specimen.
Treatment (Supplied drug: none)
Cisplatin 75 mg/m2, IV, day 1, every 3 weeks, 4 cycles OR
Carboplatin AUC 6, IV, day 1, every 3 weeks, 4 cycles
Capecitabine 1000mg/m2, PO, BID, days 1-14, every 3 weeks, 6 cycles
1 Cycle = 3 weeks
Eligibility for Screening/Step 0
- Age 18 years.
- ECOG Performance Status 0 or 1 within 2 weeks prior to screening.
- Female and male patients must have histologically confirmed invasive breast cancer that meets the following criteria:
- Clinical stage II or III (AJCC 7th edition) at diagnosis, based on initial evaluation by clinical examination and/or breast imaging; no metastatic disease allowed
- ER- and PR- should meet one of the following criteria:
- ≤ 10% cells stain positive, with weak intensity score (equivalent to Allred score ≤ 3)
- ≤ 1% cells stain positive, with weak or intermediate intensity score (equivalent to Allred score ≤ 3)
- HER2 negative (not eligible for anti-HER2 therapy) will be defined as:
- IHC 0, 1+ without ISH HER2/neu chromosome 17 ratio OR
- IHC 2+ and ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells OR
- ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells without IHC)
- Patients must have completed neoadjuvant taxane +/- anthracycline. Patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen.
- Must have completed definitive resection of primary tumor.
- Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however patients with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy. Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible.
- Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable.
- Sentinel node biopsy either pre or post neoadjuvant chemotherapy (i.e. at the time of definitive surgery) are allowed. Axillary dissection is encouraged in patients with lymph node involvement, but is not mandatory.
- Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery. Residual cancer is defined as a contiguous focus of residual invasive cancer, in the breast, measuring 1 cm in diameter, and with more than minimal cellularity, as per local pathologist determination. Please note that in patients that have multifocal or multicentric residual tumors these lesions cannot be added up; the biggest lesion has to measure 1 cm in diameter. This is required due to constraints in DNA extraction for PAM50 analysis.
- Radiotherapy may be given before or after protocol treatment per standard of care guidelines. When radiotherapy is planned prior to protocol treatment administration, patients may be registered and screened while receiving radiation. Post-mastectomy radiotherapy is required for all patients with the following:
- Primary tumor 5 cm (prior to neoadjuvant chemotherapy [clinically] or at the time of definitive surgery) or involvement of lymph nodes at the time of definitive surgery.
- For patients with primary tumors < 5 cm or without lymph node involvement prior to neoadjuvant chemotherapy and at the time of definitive surgery, provision of post-mastectomy radiotherapy is at the discretion of the treating physician.
- Breast radiotherapy (whole breast or partial) is required for patients who underwent breast-conserving therapy, including lumpectomy or partial mastectomy.
- Adequate bone marrow and organ function based on the following tests. Laboratory values must be obtained within 8 weeks prior to screening for protocol therapy.
- Hemoglobin (Hgb) > 9.0 g/dL
- Platelets > 100,000 cells/mm3
- Absolute neutrophil count (ANC) > 1500 cells/mm3
- Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula
- Bilirubin ≤ 1.5 x ULN upper limit of normal (except in patients with documented Gilbert’s disease, who must have a total bilirubin ≤ 3.0 mg/dL)
- Aspartate aminotransferase (AST, SGOT) ≤ 2.5 ULN
- Alanine aminotransferase (ALT, SGPT) ≤ 2.5 ULN
- No history of TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sort.
3.1.10 No clinically significant infections as judged by the treating investigator.
3.1.11 Patients with active CTCAE v.4 grade 2 neuropathy are ineligible.
3.1.12 Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed. LHRH agonists and adjuvant bisphosphonate or denosumab use is allowed.