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Completed

NCT Number: NCT00897702

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Neoplasms, Male Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Basking Ridge (Consent only), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Cohort 3

  • Patients not eligible for Cohorts 1 or 2.

Exclusion criteria

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

Treatment and study plan

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.

immunoenzyme technique

Other

Biopsy

Procedure

histopathologic examination

Procedure

Primary outcomes

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

Secondary outcomes

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2007
Primary completion
2026
Study completion
2026
First posted
May 12, 2009
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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