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

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ClinicalTrials.gov Identifier: NCT00897702
Recruitment Status : Recruiting
First Posted : May 12, 2009
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Breast Cancer Other: Blood draw Other: immunoenzyme technique Procedure: biopsy Procedure: histopathologic examination

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer
Study Start Date : January 9, 2007
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Other: Blood draw
    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.
    Other: immunoenzyme technique Procedure: biopsy Procedure: histopathologic examination

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
tissue and blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

All patients:

  • Diagnosed with progressive, recurrent or metastatic HER2+ or ER+ breast cancer.

Cohort 1

  • 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 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 tamoxifen, toremifene, raloxifene, anastrozole, letrozole, exemestane, fulvestrant, ARN-810) 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, but previously received treatment of any other kind for breast cancer.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897702


Contacts
Contact: Sarat Chandarlapaty, MD, PhD 646-888-5449
Contact: Pedram Razavi, MD 646-888-4568

Locations
United States, New Jersey
Memorial Sloan Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Sarat Chandarlapaty, MD, PhD    646-888-5449      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Sarat Chandarlapaty, MD, PhD    646-888-5449      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Sarat Chandarlapaty, MD, PhD    646-888-5449      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States
Contact: Sarat Chandarlapaty, MD, PhD    646-888-5449      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Sarat Chandarlapaty, MD, PhD    646-888-5449      
Memorial Sloan Kettering Cancer Center at Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11570
Contact: Sarat Chandarlapaty, MD, PhD    646-888-5449      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Sarat Chandarlapaty, MD, PhD Memorial Sloan Kettering Cancer Center
More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00897702     History of Changes
Other Study ID Numbers: 06-163
MSKCC-06163
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent breast cancer
male breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases