Estrogen Receptor NegativeHER2/Neu NegativeInvasive Breast CarcinomaProgesterone Receptor NegativeStage II Breast CancerStage IIA Breast CancerStage IIB Breast CancerStage III Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerTriple-Negative Breast Carcinoma
This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
ELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP 0)
Inclusion Criteria:
* Eastern Cooperative Oncology Group (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-III (American Joint Committee on Cancer \[AJCC\] 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:
* Immunohistochemistry (IHC) 0, 1+ without in situ hybridization (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
* NOTE: Patients that originally present with synchronous bilateral tumors are eligible provided both tumors are TNBC, and at least one of them fulfills the remainder eligibility criteria of the protocol; multifocal or multicentric breast cancers are eligible as long as all tumors fulfill eligibility criteria
* NOTE: Patients that have a discrepancy in ER/PR/HER2 status between original diagnosis and surgical specimen (if ER/PR/HER2 status were repeated) are not eligible for study participation (i.e. ER/PR/HER2 has to fulfill above criteria in both scenarios)
* Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen
* NOTE: Patients who received preoperative therapy as part of a clinical trial may enroll
* NOTE: Patients that were not able to complete their planned neoadjuvant chemotherapy for any reason (i.e. toxicities, etc.) are eligible to participate as long as no further systemic standard of care therapy is planned by the treating physician
* 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; this is required due to constraints in deoxyribonucleic acid (DNA) extraction for PAM50 analysis
* NOTE: The presence of ductal carcinoma in situ (DCIS) without invasion does not qualify as residual invasive disease in the breast
* NOTE: Despite lymph node involvement if residual invasive cancer in the breast is \< 1 cm in diameter patients are not eligible for participation
* 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 4 or more lymph nodes at the time of definitive surgery
* For patients with primary tumors \< 5 cm or with \< 4 involved lymph nodes prior to neoadjuvant chemotherapy and at the time of definitive surgery, provision of post-mastectomy radiotherapy is at the discretion of the treating physician
* Radiation of regional nodal basins is at the discretion of the treating radiation oncologist
* NOTE: Breast radiotherapy (whole breast or partial) is required for patients who underwent breast-conserving therapy, including lumpectomy or partial mastectomy
* Hemoglobin (Hgb) \> 9.0 g/dL
* Platelets \> 100,000 mm\^3
* Absolute neutrophil count (ANC) \> 1500 mm\^3
* 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, serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT, serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN
* Patients with active \>= Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 grade 2 neuropathy are ineligible
* Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed; luteinizing hormone-releasing hormone (LHRH) agonists and adjuvant bisphosphonate or denosumab use is allowed
* Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the residual disease on the definitive surgical specimen available for PAM50 analysis for stratification
* Tumor tissue specimen from the definitive surgery has been collected and is ready to ship to the ECOG-American College of Radiology Imaging Network (ACRIN) Central Biorepository and Pathology Facility (CBPF) within 21 weeks post-surgery
* The Molecular Diagnostics Laboratory (MDL) at MD Anderson Cancer Center will perform the PAM50 analysis and notify the ECOG-American College of Radiology Imaging Network (ACRIN) operations office within three (3) weeks of receipt of the tumor tissue specimen via secure electronic messaging to the ECOG-ACRIN database; results will not be reported to the submitting institution
* NOTE: Tissue must be submitted any time during screening period, even if patient is getting radiation
* NOTE: Every effort should be made to submit the tumor tissue specimen to the ECOG-ACRIN CBPF immediately
Exclusion Criteria:
* History of TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sort
* Clinically significant infections as judged by the treating investigator
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1):
* No specific timeframe between registration and randomization needs to be observed, as long as:
* Patients randomized to the chemotherapy arms have their cycle 1/ day 1 (platinum based or capecitabine) start within 3 weeks (15 working days) following randomization date
* Randomization occurs no more than 24 weeks from surgery date
* Must have PAM50 analysis by digital mRNA quantitation on the formalin-fixed paraffin-embedded tumor tissue specimen (FFPE) of the residual disease in the breast or axilla resected at the time of definitive surgery completed
* ECOG performance status 0 or 1 within 2 weeks prior to randomization
* Radiotherapy may be given before or after protocol treatment. when radiotherapy is planned prior to protocol treatment administration, patients must have completed adjuvant radiotherapy \>= 2 weeks prior to randomization for protocol therapy, if applicable
* Patients must have completed treatment with any investigational agent \>= 30 days prior to randomization for protocol therapy, if applicable
* Patients must be randomized within 24 weeks from surgery
* Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy
* A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
* Hemoglobin (Hgb) \> 9.0 g/dL
* Platelets \> 100,000 mm\^3
* Absolute neutrophil count (ANC) \> 1500 mm\^3
* International normalized ratio (INR) =\< 3 (to be done/tested only for subjects on warfarin)
* Calculated creatinine clearance of \> 50 mL/min using the Cockcroft-Gault formula
* Bilirubin =\< 1.5 x ULN (except in patients with documented Gilbert?s disease, who must have a total bilirubin =\< 3.0 mg/dL)
* Aspartate aminotransferase (AST, SGOT) =\< 2.5 x ULN
* Alanine aminotransferase (ALT, SGPT) =\< 2.5 x ULN
Primary outcome measure(s)
3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients — No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years. IDFS was defined to be time from randomization to the earliest of documented disease recurrence (local, regional and/or distant), invasive contralateral breast cancer, invasive any other second cancer, or death. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of IDFS events. 3-year IDFS rate was estimated using Kaplan-Meier method.
Trial sites (1024)
Facility
City
Region
Status
Mobile Infirmary Medical Center
Mobile
Alabama
University of South Alabama Mitchell Cancer Institute
Mobile
Alabama
Anchorage Associates in Radiation Medicine
Anchorage
Alaska
Anchorage Radiation Therapy Center
Anchorage
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska
Alaska Oncology and Hematology LLC
Anchorage
Alaska
Alaska Regional Hospital
Anchorage
Alaska
Alaska Women's Cancer Care
Anchorage
Alaska
Anchorage Oncology Centre
Anchorage
Alaska
Katmai Oncology Group
Anchorage
Alaska
Providence Alaska Medical Center
Anchorage
Alaska
Fairbanks Memorial Hospital
Fairbanks
Alaska
Kingman Regional Medical Center
Kingman
Arizona
Cancer Center at Saint Joseph's
Phoenix
Arizona
Banner University Medical Center - Tucson
Tucson
Arizona
University of Arizona Cancer Center-North Campus
Tucson
Arizona
Mercy Hospital Fort Smith
Fort Smith
Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs
Arkansas
Kaiser Permanente-Deer Valley Medical Center
Antioch
California
PCR Oncology
Arroyo Grande
California
Sutter Auburn Faith Hospital
Auburn
California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
California
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
California
Mills-Peninsula Medical Center
Burlingame
California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
California
Eden Hospital Medical Center
Castro Valley
California
Sutter Davis Hospital
Davis
California
Epic Care-Dublin
Dublin
California
Kaiser Permanente Dublin
Dublin
California
Bay Area Breast Surgeons Inc
Emeryville
California
Epic Care Partners in Cancer Care
Emeryville
California
Kaiser Permanente-Fremont
Fremont
California
Palo Alto Medical Foundation-Fremont
Fremont
California
Fresno Cancer Center
Fresno
California
Kaiser Permanente-Fresno
Fresno
California
Cedars Sinai Medical Center
Los Angeles
California
Contra Costa Regional Medical Center
Martinez
California
Memorial Medical Center
Modesto
California
Kaiser Permanente-Modesto
Modesto
California
+ 984 more sites — see the full list on the official registry below.
More ECOG-ACRIN Cancer Research Group trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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