Recruiting

Molecular Profiling

Sponsor:

Texas Tech University Health Sciences Center, El Paso

Code:

NCT04362462

Conditions

Triple-negative Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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 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.

Conditions

Triple-negative Breast Cancer

Study ID

NCT04362462

Start date

Mar 5, 2019

Status verified date

Apr, 2020

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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).
2. 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).
3. Patient must be eligible for neo-adjuvant chemotherapy, and surgical lumpectomy or mastectomy.
4. 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 Criteria:

1. Women < 18 or >86 years of age
2. ER/PR- positive, Her-2 neu - positive breast cancer.

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Progression Free Survival [ Time Frame: 12-24 months ]

Central Contacts and Locations

Central contacts

Locations

Texas Tech University Health Sciences Center- El Paso

Recruiting

El Paso, Texas, United States, 79905

Contacts

More Information

Sponsor

Texas Tech University Health Sciences Center, El Paso

Last update posted

Apr 27, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center, El Paso on 2020-04-27.