Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive

Conditions

• Estrogen Receptor Positive
• HER2 Positive Breast Carcinoma
• HER2/Neu Negative
• Progesterone Receptor Positive
• Recurrent Breast Carcinoma
• Stage IIIB Breast Cancer AJCC v7
• Stage IIIC Breast Cancer AJCC v7
• Stage IV Breast Cancer AJCC v6 and v7

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fulvestrant — DRUG
  Given IM
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Lapatinib Ditosylate — DRUG
  Given PO
• Placebo Administration — OTHER
  Given PO

Study Details

This randomized phase III trial studies fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without lapatinib in treating breast cancer.

Key Dates

Start date

Sep 15, 2006

Status verified

Nov 2019

Primary completion

Jul 1, 2014

Completion

Jul 2, 2014

Study Design

Enrollment

295 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (lapatinib)
  Patients receive lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 and 15 of course 1 and on day 1 of each subsequent course. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
• Placebo Comparator: Arm II (placebo)
  Patients receive placebo PO QD on days 1-28 and fulvestrant as in Arm I. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years ]

Locations (368)

Find similar trials in Little Rock, AR

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