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

NCT00897702 | Completed

• 2 other identifiers: 06-163MSKCC-06163
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; male breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (3)

• To look for mutations in druggable oncogenic pathways in tumors progressing on anti-HER2 therapy or hormonal therapy

  3 years

• To characterize the activity of the PI3K signaling pathway in progressive breast tumors using proteomic methods

  3 years

• To develop new laboratory models of treatment refractory breast cancer from human tumor specimens

  3 years

Secondary Outcomes (3)

• To look for mutations in druggable oncogenic pathways in tumor progressing on breast cancer targeted therapies

  3 years

• To evaluate dynamic proteomic changes in response to inhibition of the RTK/PI3K/ATK/mTOR pathway.

  3 years

• To characterize the genetic heterogeneity of progressive, metastatic tumors using next generation sequencing

  3 years

Interventions

Blood draw OTHER

A single 10ml tube of blood will also be obtained for a comparison of patient's normal DNA for genomic analyses either at the time of the procedure or at a followup appointment if feasible.

biopsy PROCEDURE

immunoenzyme technique OTHER

histopathologic examination PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).

You may qualify if:

• 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.
• Cohort 3
• Patients not eligible for Cohorts 1 or 2.

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

tissue and blood

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Blood Specimen Collection; Immunoenzyme Techniques; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Immunoassay; Immunologic Techniques; Immunohistochemistry; Molecular Probe Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• Sarat Chandarlapaty, MD, PhD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: January 9, 2007
• Primary Completion: January 23, 2026
• Study Completion: January 23, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (7)