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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/27/2019
Start Date:January 9, 2007
End Date:January 2020
Contact:Sarat Chandarlapaty, MD, PhD
Phone:646-888-5449

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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.


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
We found this trial at
7
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-5449
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Phone: 646-888-5449
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650 Commack Road
Commack, New York 11725
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500 Westchester Avenue
Harrison, New York 10604
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480 Red Hill Road
Middletown, New Jersey 07748
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225 Summit Avenue
Montvale, New Jersey 07645
Phone: 646-888-4311
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1275 York Avenue
Rockville Centre, New York 11570
Phone: 646-888-5449
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Rockville Centre, NY
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