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Endocrine Therapy With or Without Inhibition of EGF and HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib (GW572016) for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

Phase 3
18 Years
Open (Enrolling)
Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

Endocrine Therapy With or Without Inhibition of EGF and HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib (GW572016) for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer


I. Compare the progression-free survival of postmenopausal women with stage III or IV
hormone receptor-positive breast cancer treated with fulvestrant with or without lapatinib


I. Compare the response rate in patients treated with these regimens. II. Compare response
and stable disease rate (i.e., complete response, partial response, and stable disease > 6
months) in patients treated with these regimens.

III. Compare the duration of response in patients treated with these regimens. IV. Compare
the overall survival of patients treated with these regimens. V. Compare the quality of life
of patients treated with these regimens. VI. Compare the toxicity of these regimens in these

OUTLINE: This is a multicenter, open-label, randomized, double-blind, placebo-controlled
study. Patients are stratified according to prior tamoxifen citrate therapy (yes vs no) and
bone disease only (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral lapatinib ditosylate once daily on days 1-28 and fulvestrant
intramuscularly (IM) on days 1 and 15 of course 1 and on day 1 of each subsequent course.

ARM II: Patients receive oral placebo once daily on days 1-28 and fulvestrant as in arm I.

In both arms, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity. Quality of life is assessed at baseline and then on day 1 of every 2
courses of treatment (i.e., day 1 of courses 3, 5, 7, etc.).

After completion of study treatment, patients are followed every 6 months for 2 years and
then annually for 3 years.

Inclusion Criteria:

- Histologically* or cytologically confirmed breast cancer, meeting 1 of the following
stage criteria:

- Stage III (locally advanced) disease not considered amenable to curative therapy

- Stage IV (primary or metastatic) disease

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by
conventional techniques or ≥ 1.0 cm by spiral CT scan

- Lytic or blastic bone metastases as only site of disease allowed

- The following are not considered measurable disease:

- Bone lesions (except as above)

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast cancer

- Lymphangitis cutis/pulmonitis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Must have received prior therapy with 1 or 2 endocrine treatments for breast cancer
in either the adjuvant or metastatic setting (not including treatment for ovarian
suppression or amenorrhea)

- Tumor must be potentially sensitive to endocrine therapy, defined as ≥ 3 months
of prior endocrine therapy without disease progression in the adjuvant or
metastatic setting

- Treatments must have been commercially-available third-generation aromatase
inhibitors (e.g., anastrozole, exemestane, or letrozole)*

- No symptomatic brain or other CNS metastases

- Previously treated brain metastases allowed provided patient is free of symptoms
AND > 3 months since prior treatment for brain metastases

- Hormone receptor status:

- Estrogen receptor- and/or progesterone receptor-positive tumor by IHC methods (≥
1% cells considered positive)

- Female

- Postmenopausal, meeting 1 of the following criteria:

- Age ≥ 60 years

- Age ≥ 45 years with an intact uterus and amenorrhea for ≥ 12 months

- History of bilateral oophorectomy

- Follicle-stimulating hormone levels within postmenopausal range

- Undergoing treatment with a gonadotropin-releasing hormone agonist for ovarian
suppression for ≥ 3 consecutive months prior to study entry, and remains on such
therapy throughout study treatment

- Life expectancy > 3 months

- ECOG performance status 0-2

- Granulocyte count ≥ 1,000/mm³

- Platelet count ≥ 100,000/mm³

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert's

- Creatinine ≤ 2.0 mg/dL

- AST and ALT ≤ 2.5 times ULN (5 times ULN for patients with liver metastases)

- INR ≤ 1.6

- LVEF normal

- Not pregnant or nursing

- Negative pregnancy test

- No pending visceral crisis

- No acquired or inherited bleeding disorder

- No other concurrent endocrine therapy, including systemic hormone-replacement therapy
or intravaginal estrogen

- Prior initiation of and concurrent bisphosphonate therapy allowed

- At least 2 weeks since prior chemotherapy and recovered

- Prior chemotherapy in the adjuvant and/or neoadjuvant setting allowed

- No more than 1 prior chemotherapy regimen for stage IV breast cancer

- At least 3 weeks since prior trastuzumab (Herceptin®) and recovered

- Prior trastuzumab in the adjuvant and/or neoadjuvant setting allowed

- No prior trastuzumab for stage IV breast cancer

- No prior fulvestrant

- No prior epidermal growth factor receptor (EGFR) inhibitors (e.g., gefitinib,
erlotinib hydrochloride, lapatinib ditosylate, or cetuximab)

- No other prior or concurrent experimental EGFR inhibitors

- No other concurrent chemotherapy

- No concurrent radiotherapy, including palliative radiotherapy

- No other concurrent hormonal therapy* except for the following:

- Steroids for adrenal failure

- Hormones for nondisease-related conditions (e.g., insulin for diabetes or
synthroid for hypothyroidism)

- Intermittent dexamethasone as an antiemetic

- No concurrent therapeutic systemic anticoagulation (defined as maintaining INR > 1.6)

- Low-dose warfarin or acetylsalicylic acid (or equivalent) for maintenance of
central venous catheter patency allowed

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

One-sided O'Brien-Fleming boundaries will be used to stop for superiority. Futility boundaries will be based on testing the alternative hypothesis at a one-sided 0.005 alpha level, as recommended by Freidlin and Korn. Specifically, Z-score futility boundaries will be calculated as 2.576 + log(1.5)*sqrt (n/4), where n is the total number of observed events. The final analysis will use the stratified log-rank test to test for a difference between the treatment arms in PFS (one-sided alpha of 0.025) where the stratification factors are prior tamoxifen (yes/no) and bone-only disease (yes/no).

Outcome Time Frame:

Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years

Safety Issue:


Principal Investigator

Harold Burstein

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

Related Keywords:

  • Recurrent Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms



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