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AN OPEN-LABEL RANDOMIZED, PARALLEL, TWO-ARM PHASE II STUDY COMPARING BMS-690514 + LETROZOLE WITH LAPATINIB + LETROZOLE IN RECURRENT AND METASTATIC BREAST CANCER PATIENTS WHO ARE HORMONE RECEPTOR POSITIVE DESPITE HER2 STATUS AND WHO RELAPSED WHILE RECEIVING OR AFTER COMPLETING ADJUVANT ANTIENDOCRINE THERAPY

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-010-10
Enrollment
25
Registered
2010-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

To be random approximately 140 patients in a 1: 1 ratio to receive BMS-690514 / letrozole or lapatinib / letrozole. It is expected to analyze the primary endpoint of CBR FPFV 28 months after assuming

Sponsors

BRISTOL MYERS SQUIBB COMPANY,
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: • 1) Informed written consent approved by the IRB / IEC voluntarily signed and dated form in accordance with the guidelines. 2) Invasive breast cancer documented histologically positive for ER + and / or PgR + in 10% of tumor cells or more, with tumor tissue from previous surgery available for analysis of ER / PR, EGFR, PTEN and PIK3CA. 3) Patients must have previously received adjuvant therapy for breast cancer with tamoxifen or exemestane anastraozol. the sequential use of antihormonal agents are allowed. 4) Patients receiving cytotoxic chemotherapy (adjuvant setting in metastatic, or neoadjuvant) therapy must have completed at least 4 weeks before the first dose of randomized study medication.

Exclusion criteria

Exclusion criteria: • 1) Patients who have received prior hormonal therapy for metastatic disease. 2) Patients who have received prior hormonal therapy for metastatic disease. 3) Symptomatic patients with brain metastases. 4) Patients with signs or symptoms suggestive of understanding

Countries

Argentina, Mexico, Peru, United States

Contacts

Public ContactUrsula Noto

BRISTOL MYERS SQUIBB PERU S.A.

ursula.noto@bms.com4418204

Outcome results

None listed

Source: REPEC (via WHO ICTRP)