RO4929097 and Letrozole in Treating Post-Menopausal Women With Hormone Receptor-Positive Stage II or Stage III Breast Cancer

Stopped early · Phase 1

Conditions studied: Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Progesterone Receptor-positive Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer

In brief

This phase I trial is studying the side effects and best dose of RO4929097 when given together with letrozole in treating post-menopausal women with stage II or stage III breast cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving RO4929097 together with letrozole may be an effective treatment for breast cancer.

Key facts

Study ID

NCT01208441

Run by

National Cancer Institute (NCI)

People needed

28

Starts

2010-11-01

Last updated by the study team

2013-09-30

Who can join

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

You may qualify if…

• Pathologically confirmed invasive breast cancer
• Stage II or III disease (T2-T3, N0-2)
• No N3, T4 disease
• Estrogen receptor-positive (ER+) and/or progesterone receptor-positive (PR+)
• H score ≥ 10 or positivity ≥ 10%
• HER2 negative as determined by IHC (1 or 2+) or FISH (< 2.0+)
• Bilateral disease allowed as long as all tumors are ER+ and ≥ 1 is T2-T3
• Patient must have disease that is palpable on physical exam and able to be imaged via breast ultrasound
• Defined as ≥ 1 T2 tumor > 2 cm
• Multifocal disease allowed provided that ≥ 1 of the tumors is > 2 cm
• No metastatic disease by CT scans of the chest, abdomen, and pelvis, a PET/CT bone scan, or nuclear medicine bone scan
• No inflammatory breast cancer or presence of breast tumor cells in the dermal lymphatics of the breast
• Post-menopausal meeting 1 of the following criteria:
• Bilateral oophorectomy
• Age ≥ 50 years and amenorrheic for > 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression (spontaneous amenorrhea)
• ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
• Life expectancy > 3 months
• ANC ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Total bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Baseline QTcF ≤ 470 msec
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gamma secretase inhibitor RO4929097 or other agents used in the study

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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