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

Stopped early · Phase 2

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT02115048

Run by

Translational Research in Oncology

People needed

44

Starts

2014-07-01

Expected to finish

2018-11-01

Last updated by the study team

2019-12-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• St. Jude Heritage Healthcare — Fullerton, California, United States
• University of California Los Angeles Hematology Oncology — Los Angeles, California, United States
• West Valley Hematology Oncology Medical Group — Northridge, California, United States
• DBA Torrance Memorial Physician Network/Cancer Care Associates — Redondo Beach, California, United States
• Coastal Integrative Cancer Care — San Luis Obispo, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• Orlando Health, Inc. — Orlando, Florida, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Hope Women's Cancer Centers — Asheville, North Carolina, United States
• University Hospital Clinical Center Banja Luka, Oncology Clinic — Banja Luka, Bosnia and Herzegovina
• Clinical Center of University in Sarajevo, Clinic for Oncology — Sarajevo, Bosnia and Herzegovina
• University Clinical Center Tuzla Clinic for Oncology, Hematology and Radiotherapy — Tuzla, Bosnia and Herzegovina
• Filantropia Clinical Hospital — Bucharest, Romania
• County Emergency Clinical Hospital Cluj-Napoca Oncology Department — Cluj-Napoca, Romania
• SC Medisprof SRL — Cluj-Napoca, Romania
• County Hospital Ploiesti — Ploieşti, Romania
• County Emergency Hospital "Sf Ioan cel Nou" — Suceava, Romania
• Oncomed SRL Timisoara — Timișoara, Romania
• Complexo Hospitalario Universitario A Coruña — A Coruña, Spain
• Complejo Hospitalario Universitario de Albacete — Albacete, Spain
• Hospital General Universitario de Alicante — Alicante, Spain
• Hospital de Especialidades de Jerez de La Frontera — Jerez de la Frontera, Spain
• Hospital Clínico Universitario Virgen de La Arrixaca — Murcia, Spain
• Hospital Son Llatzer — Palma de Mallorca, Spain
• Hospital Universitari de Sant Joan de Reus — Reus, Spain

Full record on ClinicalTrials.gov

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