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Molecular Mechanisms of Clinical Resistance to Anti-HER2 Therapy Among Patients With HER2 Amplified Breast Cancer

Open (Enrolling)
Breast Cancer

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Trial Information

Molecular Mechanisms of Clinical Resistance to Anti-HER2 Therapy Among Patients With HER2 Amplified Breast Cancer

Inclusion Criteria:

- Patients diagnosed with progressive, recurrent or metastatic HER2+ breast cancer and
who fulfill the following eligibility criteria will be considered eligible for this

- Patients who previously received treatment with anti-HER2 therapy (including
trastuzumab, pertuzumab, TDM1, or lapatinib) 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 (e.g. radiologic
progression by WHO criteria or new metastasis).

- Patients with a prior tumor biopsy (may be original) defined as HER2+ by
amplification by FISH (>1.9 gene copy number) or IHC 3+.

For the purposes of establishing baselines in some of the assays, separate from the above
inclusion criteria, a cohort of patients diagnosed with any recurrent breast cancer will
be eligible under the following criteria:

- Previously received treatment of any kind for breast cancer and now have recurrent
breast cancer.

Exclusion Criteria:

- Patients who are unable to consent to a biopsy.

- Patients for whom a repeat biopsy would be medically unsafe

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Comparison of expression levels of PTEN prior to treatment with HER2-targeting agents with levels after disease progression/recurrence

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Sarat Chandarlapaty

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2007

Completion Date:

January 2014

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • male breast cancer
  • stage IV breast cancer
  • Breast Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Rockville Centre, New York  11570
Memorial Sloan-Kettering at Basking Ridge Basking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
Memoral Sloan Kettering Cancer Center@Phelps Sleepy Hollow, New York