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A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer


Phase 2
16 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer


OBJECTIVES:

Primary

- Determine the efficacy of 2 different treatment schedules of everolimus, in terms of
clinical/radiological response and early progression, in patients with recurrent or
metastatic breast cancer.

Secondary

- Determine the time to progression and response duration in patients treated with these
regimens.

- Determine the toxic effects of these regimens in these patients.

- Correlate molecular markers of mTOR activity in tumor tissue with objective tumor
response in patients treated with these regimens.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to presence of visceral metastases (yes vs no) and prior chemotherapy regimens for
recurrent disease (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral everolimus once daily on days 1-28.

- Arm II: Patients receive oral everolimus on days 1, 8, 15, and 22. In both arms,
courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed at 4 weeks and then periodically
until disease progression.

PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed breast cancer

- Metastatic or recurrent disease

- Considered incurable

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques or ≥ 10 mm by spiral CT scan

- Two primary breast cancers allowed

- Paraffin-embedded primary or metastatic tumor sample available

- No known brain metastases

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Sex

- Male or female

Menopausal status

- Not specified

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

Renal

- Creatinine ≤ 1.5 times ULN

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active uncontrolled infection

- No upper gastrointestinal condition or other condition that would preclude ability to
take oral medication

- No other serious medical condition that would preclude study participation

- No psychiatric illness or neurologic disorder that would preclude study compliance

- No other malignancy within the past 5 years except curatively treated nonmelanoma
skin cancer or carcinoma in situ of the cervix or bladder

PRIOR CONCURRENT THERAPY:

Chemotherapy

- At least 4 weeks since prior chemotherapy

- Prior adjuvant chemotherapy allowed

- No more than 1 prior chemotherapy regimen for metastatic or recurrent disease

Endocrine therapy

- At least 5 days since prior hormonal therapy

Radiotherapy

- At least 4 weeks since prior radiotherapy except for low-dose, limited-fraction,
palliative, nonmyelosuppressive radiotherapy, defined as radiotherapy to < 20% of
functioning bone marrow

- If prior radiotherapy was to sole site of disease, must have subsequent documented
disease progression at that site

Surgery

- At least 3 weeks since prior major surgery

Other

- Concurrent prophylactic bisphosphonates allowed, if started prior to study entry

- No concurrent potent inhibitors of cytochrome 3A4, such as erythromycin, diltiazem,
or ketoconazole and similar antifungals

- No other concurrent anticancer therapy

- No other concurrent investigational agents

- No concurrent grapefruit juice

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks

Safety Issue:

No

Principal Investigator

Susan Ellard, MD

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency - Centre for the Southern Interior

Authority:

United States: Federal Government

Study ID:

I163

NCT ID:

NCT00255788

Start Date:

January 2005

Completion Date:

January 2011

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • male breast cancer
  • Breast Neoplasms

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