Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone

• Status: Terminated
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to compare the efficacy of treatment with afatinib plus letrozole to treatment with letrozole alone in women diagnosed with a specific type of breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Research in Oncology
• Collaborator: Boehringer Ingelheim
• Treatments: Afatinib; Letrozole

Criteria

Inclusion Criteria:

• Signed and dated informed consent.

• Postmenopausal females, 18 years of age or older.

• Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease.

• HER2 negative breast cancer. Central testing (required for all subjects) must demonstrate that the tumor is HER2 negative by FISH or Immunohistochemistry (IHC).

• ER positive breast cancer. Central testing (required for all subjects) must demonstrate that the tumor is ER+ with low expression (H-score [1-159]).

• Paraffin-embedded tumor block(s) or 15 to 20 unstained slides available for centralized assessment of ER, PR, and HER2.

• Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 or bone-only non measurable disease.

• Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1.

• Adequate hematological, hepatic and renal functions.

• Baseline left ventricular ejection fraction (LVEF) 50%.

• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

• Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.

• Prior treatment with any type of systemic therapy for advanced disease.

• Prior treatment with letrozole in (neo)adjuvant setting with disease-free interval ≤ 12 months from completion of treatment until randomization.

• Prior treatment with any anti HER-family targeted therapy in (neo)adjuvant setting.

• Any concurrent or previous malignancy within 5 years prior to randomization, except for adequately and radically treated basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm.

• Non-measurable disease according to RECIST 1.1, with the exception of bone-only non-measurable disease.

• Known pre-existing interstitial lung disease.

• Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom.

• History or presence of clinically relevant cardiovascular abnormalities as per investigator assessment.

• Any other concomitant serious illness or organ system dysfunction as per investigator assessment

• Any contraindication to oral agents.

• Active hepatitis B infection, active hepatitis C infection or known HIV carrier.

• Known or suspected active drug or alcohol abuse.

• Known hypersensitivity to afatinib or letrozole or the excipients of any of the trial drugs.

• Concomitant treatment with strong inhibitor of P-gp.

• Any ongoing acute clinically significant toxic effect of prior anticancer therapy or any persisting complication of prior surgery.

• Subjects with known history of keratitis, ulcerative keratitis or severe dry eye.

• Participation in the active phase of other clinical trials of investigational agents in which last study treatment was administered within 2 weeks prior to randomization