Featured Clinical Trial:
Post-menopausal breast cancer (product/compound: Bosutinib and Letrozole)
ClinicAid Locations: Southern California – Corona
Status: Enrollment closed.
Condition: Breast Cancer
Product Name/Compound: Bosutinib; Letrozole
Full Study Title: A Phase 2, Randomized, Open-label Study of Bosutinib Administered in Combination With Letrozole Versus Letrozole Alone as First Line Therapy in Post-Menopausal Women With Locally Advanced or Metastatic ER+/PgR+/ErbB2 – Breast Cancer
Study Summary: This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28 days. The second part will proceed with subjects receiving a dose that is determined to be safe based on the safety evaluation of the first part. Eligible subjects will be randomly assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole alone for a specified period of time. Subjects will be followed up for survival after study drug discontinuation.
Eligible Participants:
Inclusion (Eligible):
- Surgically sterile or post-menopausal women
- Confirmed pathologic diagnosis of breast cancer.
- Locally advanced or metastatic, or loco-regional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
- Documented ER+ and/or PgR+ and erbB2- tumor based on most recently analyzed biopsy, as documented by a local laboratory
- At least 1 radiologically measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
Exclusion (Not Eligible):
- Prior letrozole (except in adjuvant setting), prior bosutinib, or any other prior Src inhibitor.
- Prior endocrine treatment for locally advanced or metastatic breast cancer (up to one prior adjuvant Aromatase Inhibitor (AI) agent/regimen is permitted).
- More than 1 prior chemotherapy regimen in locally advanced or metastatic breast cancer
- Adjuvant endocrine therapy ≤12 months prior to day 1 of treatment.
- Disease refractory (i.e. Progressive disease (PD) within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy.
- Bone or skin as the only site of disease.
- Extensive visceral disease or active Central Nervous System (CNS) disease.
- Any other cancer within 5 years of screening with the exception of ER+ contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
- History of clinically significant or uncontrolled cardiac disease.
- Serious concurrent illness.
Study Phase: Phase II (What are Phases?)
To receive information and updates for this trial:
Please contact us and mention the Trial ID below.
Trial ID (ClinicalTrials.gov): NCT0880009
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