Status:
UNKNOWN
Molecular Profiling After Neoadjuvant Chemotherapy for Triple-negative Breast Cancer
Lead Sponsor:
Texas Tech University Health Sciences Center, El Paso
Conditions:
Triple-negative Breast Cancer
Eligibility:
FEMALE
18-86 years
Brief Summary
Neoadjuvant chemotherapy (NACT) can induce complete pathologic response (pCR) in approximately 35-55% of patient with triple-negative breast cancer (TNBC). These patients have excellent long term surv...
Detailed Description
In this study, investigators will understand the clinical relevance of genomic heterogeneity of triple-negative breast cancer by determining pathological complete response (pCR) rates after NACT, base...
Eligibility Criteria
Inclusion
- Age \> 18 or \<86 years of age, for Hispanic/Latino women we will use the National Advisory Committee on Racial, Ethnic and Other populations NAC definition which is (the ethnonyms "Hispanic" and "Latino" to refer collectively to the inhabitants of the United States of America who are of Latin American or Spanish origin-that is, Latino or Hispanic Americans).
- Pre- and Post - menopausal women with histologically confirmed hormonal receptor negative (ER and/or PR \<1%), Her2-neu - negative (by IHC or/and FISH) invasive breast cancer stages I - III or with metastatic triple-negative breast cancer (if develop metastatic disease during the chemotherapy or within 24 months after completion of all appropriate treatments).
- Patient must be eligible for neo-adjuvant chemotherapy, and surgical lumpectomy or mastectomy.
- All patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with Institutional and Federal guidelines.
Exclusion
- Women \< 18 or \>86 years of age
- ER/PR- positive, Her-2 neu - positive breast cancer.
Key Trial Info
Start Date :
March 5 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04362462
Start Date
March 5 2019
End Date
December 31 2023
Last Update
April 27 2020
Active Locations (1)
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1
Texas Tech University Health Sciences Center- El Paso
El Paso, Texas, United States, 79905