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Molecular Profiling After Neoadjuvant Chemotherapy for Triple-negative Breast Cancer

Genomic/Molecular Profiling of Residual Disease After Neoadjuvant Chemotherapy in Hispanic/ Latino Women With Triple-negative Breast Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04362462
Enrollment
120
Registered
2020-04-27
Start date
2019-03-05
Completion date
2023-12-31
Last updated
2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple-negative Breast Cancer

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.

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, based on genomic profiling of individual tumors. Investigators will identify new genomic alterations in patients with residual TNBC as well as in patients who develop metastatic disease within 24 months after completion of all appropriate therapies. Investigators will demonstrate unique genomic alteration, and we will identify new tumor markers in Hispanic/Latino (H/L) women with TNBC. Inclusion Criteria: This study aims to include all patients with early stage (I-III) TNBC who received NACT and subsequently underwent surgical treatment (mastectomy or lumpectomy) or women with triple-negative breast cancer who progressed and developed metastatic disease within 24 months after all appropriate therapies. 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. Patients must be eligible for NACT, 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.

Interventions

None listed

Sponsors

Texas Tech University Health Sciences Center, El Paso
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 86 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Progression Free Survival12-24 monthsProgression free survival at one and two years in order to avoid unnecessary chemotherapy in patients with chemotherapy resistant tumors. We will measure and track the response rate to chemotherapy as well as pathological complete response after chemotherapy.

Countries

United States

Contacts

Primary ContactAlexander Philipovskiy, MD, PhD
alexander.philipovskiy@ttuhsc.edu9158155195
Backup ContactBrenda Castillo, BS
brenda.castillo@ttuhsc.edu9152154831

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026