Phase 2, Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-sensitive Metastatic Breast Cancer

• Status: Withdrawn
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole +/- goserelin (the latter for pre-menopausal women only) may fight breast cancer by lowering the amount of estrogen the body makes. OSI-906 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hormone therapy and OSI-906 are more effective when given with or without erlotinib hydrochloride in treating hormone-sensitive metastatic breast cancer.

PURPOSE: This phase II trial is studying how well giving hormone therapy together with OSI-906 with or without erlotinib hydrochloride works in treating hormone-sensitive patients with metastatic breast cancer.

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

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride; Goserelin; Hormones; Letrozole

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast carcinoma

• Stage IV disease

• No locally recurrent resectable disease

• No symptomatic brain metastases

• History of brain metastases allowed provided the patient is clinically stable for > 3 weeks after completion of radiotherapy AND is not taking steroids or therapeutic anticonvulsants that are CYP3A4 modifiers

• Hormone receptor status:

• Estrogen receptor and/or progesterone receptor positive tumor by immunohistochemistry (IHC)

PATIENT CHARACTERISTICS:

• Pre- or post-menopausal

• ECOG performance status 0-1

• Life expectancy ≥ 6 months

• ANC ≥ 1,250/mm^3

• Platelet count ≥ 100,000/mm^3

• Creatinine ≤ 1.5 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN (≤ 3 times ULN if liver metastasis is present)

• For patients with Gilbert syndrome, direct bilirubin will be measured instead of total bilirubin

• SGOT and SGPT ≤ 1.5 times ULN (≤ 3 times ULN if liver metastasis is present)

• Alkaline phosphatase ≤ 1.5 times ULN (≤ 3 times ULN if liver metastasis is present)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception during and for 3 months after completion of study therapy

• Able to swallow and retain oral medication

• Baseline QTc ≤ 450 msec

• No other invasive cancer within the past 5 years except for completely resected basal cell or squamous cell skin cancer or successfully treated cervical carcinoma in situ

• No malabsorption syndrome significantly affecting gastrointestinal function

• No diabetes, fasting glucose > 150mg/dL, or receiving ongoing anti-hyperglycemic therapies

• No concurrent uncontrolled illness including, but not limited to, any of the following:

• Ongoing or active infection requiring parenteral antibiotics

• Impaired lung function (i.e., COPD or lung conditions requiring oxygen therapy)

• Symptomatic congestive heart failure (NYHA class III or IV heart disease)

• Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within the past 6 months

• Uncontrolled hypertension, defined as systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg on two consecutive measurements taken ≥ 1 week apart, despite adequate medical support

• Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia that is symptomatic or requires treatment)

• Psychiatric illness and/or social situation that would compromise patient safety or limit compliance with study requirements, including maintenance of a compliance/pill diary

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior therapy

• At least 2 weeks since prior investigational drugs

• No more than 4 prior chemotherapy treatments in the metastatic setting

• Does not include endocrine therapy or single-agent biologic therapy

• No concurrent CYP3A4 or CYP1A2 modifiers

• No other concurrent anticancer therapy, including chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, or biologic therapy

• Concurrent radiotherapy to painful bone metastases or areas of impeding bone fracture allowed provided radiotherapy is initiated before study therapy