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- Study Description
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In this phase Ib/II clinical trial, the investigators evaluated the efficacy and safety of the combination of palbociclib with bazedoxifene in patients with a metastatic endocrine-resistant hormone receptor-positive, HER2-negative breast cancer. Furthermore, whole exome sequencing of cell-free tumor DNA was done on serial samples from these patients, revealing potential molecular changes associated with mechanisms of resistance.
- Study Design:
- Clinical Trial
- Study Type:
- Prospective
- Total number of consented subjects: 32
- Subject Sample Telemetry Report (SSTR)
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- Gene
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- Study Inclusion/Exclusion Criteria
We enrolled female or male patients, aged 18 years or older, with histologically confirmed invasive breast cancer that was metastatic or unresectable locally advanced disease. The tumors were hormone receptor positive, HER2-negative. Progressive disease on prior endocrine treatment was required. Prior therapy with up to two lines of chemotherapy was allowed. There was no limit to the number of prior endocrine therapies.
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- Study Attribution
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Principal Investigators
- Rinath Jeselsohn, MD. Dana-Farber Cancer Institute, Boston, MA, USA.
- Gad Getz, PhD. Broad Institute of MIT and Harvard, Cambridge, MA, USA.
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Principal Investigators