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Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer

NCT00897702•Memorial Sloan Kettering Cancer Center

Summary

The purpose of this study is to learn why certain drugs stop working in patients.In lab studies, tumors become resistant in several ways. Specific molecules seem to change and this may be why therapy stops working. However, we do not know if the same molecules change in patients. This study is being done to see if they do change. If we learn more about how patients become resistant, we may be able to offer better treatment in the future.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All patients:
•Diagnosed with breast cancer.
•Patient must be able to consent to a biopsy
•Patient must be able to safely undergo a secondary biopsy, if needed.
•Cohort 1
•Patients who previously received treatment with anti-HER2 therapy (including trastuzumab, pertuzumab, TDM1, lapatinib, neratibin, or DS8201) as part of adjuvant chemotherapy and now have progressive or recurrent breast cancer or, patients who previously (or currently) received anti-HER2 therapy as part of a regimen for metastatic breast cancer and subsequently experienced.
•Evidence of disease progression or recurrence after prior therapy (e.g. radiologic progression by RECIST criteria or new metastasis).
•Prior tumor biopsy (may be original) defined as HER2+ by amplification by FISH (\>1.9 gene copy number) or IHC 3+.
•Cohort 2
•Patients who previously received treatment with hormonal therapy (including aromatase inhibitors or SERMs or SERDs) as a part of adjuvant therapy and now have progressive or recurrent breast cancer or patients who previously (or currently) receive hormonal therapy as part of a regimen for metastatic breast cancer and subsequently experienced evidence of disease progression.
+1 more criteria

Exclusion Criteria

•Patients who are unable to consent to a biopsy.
•Patients for whom a repeat biopsy would be medically unsafe

Locations (7)

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent only)

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, United States

Key Dates

Start Date

January 9, 2007

Primary Completion Date

January 23, 2026

Completion Date

January 23, 2026

Last Updated

January 28, 2026

Enrollment

269

ACTUAL participants

Conditions

Breast Cancer

Interventions

Blood draw

OTHER

immunoenzyme technique

OTHER

biopsy

PROCEDURE

histopathologic examination

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer