Molecular Profiling After Neoadjuvant Chemotherapy for Triple-negative Breast Cancer
Status unconfirmed
Conditions studied: Triple-negative Breast Cancer
In brief
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 survivals. On the other hand patients with residual disease exhibit a high rate of local or metastatic. Although it has been successful in some regards, randomized trials have shown similar rates of mortality between patients receiving NACT and adjuvant chemotherapy (ACT). The goal of this study is to understand the molecular biology (gene expression signature) driving treatment-resistant TNBC. The investigators are planning to identify targetable genetic alterations which may help to optimize adjuvant therapy for the patient with residual TNBC.
Key facts
- Study ID
- NCT04362462
- Run by
- Texas Tech University Health Sciences Center, El Paso
- People needed
- 120
- Starts
- 2019-03-05
- Expected to finish
- 2023-12-31
- Last updated by the study team
- 2020-04-27
Who can join
Age: 18 and older, up to 86. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Women < 18 or >86 years of age
- ER/PR- positive, Her-2 neu - positive breast cancer.
Where it is running
- Texas Tech University Health Sciences Center- El Paso — El Paso, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.