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

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.

Study Overview

• Status: Recruiting
• Conditions: Triple-negative Breast Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Alexander Philipovskiy, MD, PhD; Phone Number: 9158155195; Email: alexander.philipovskiy@ttuhsc.edu
• Study Contact Backup: Name: Brenda Castillo, BS; Phone Number: 9152154831; Email: brenda.castillo@ttuhsc.edu

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79905
      • Recruiting
      • Texas Tech University Health Sciences Center- El Paso
      • Contact: Brenda Castillo, BS; Phone Number: 9152154831; Email: brenda.castillo@ttuhsc.edu
      • Contact: Alexander Philipovskiy, MD, PhD; Phone Number: 915-215-5195; Email: alexander.philipovskiy@ttuhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 86 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Females with confirmed triple-negative breast cancer.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	Progression 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.	12-24 months

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center, El Paso

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2019
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (ACTUAL): April 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: E19059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No