Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women

Stanford University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Anastrozole (Arimidex); Drug: Goserelin (Zoladex)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00186121

IRB-13429

1033VS0012 (Other Identifier)

75597 (Other Identifier)

BRSMTS0001 (Other Identifier)

Details and patient eligibility

About

To evaluate the antitumor activity, toxicity, and effectiveness of the combination of goserelin (Zoladex) and anastrozole (Arimidex) in the treatment of premenopausal women with hormone receptor positive metastatic carcinoma of the breast.

Full description

Pre-menopausal women with estrogen and/or progesterone receptor positive, metastatic or recurrent breast cancer were enrolled and treated with goserelin (Zoladex) monthly and began anastrozole (Arimidex) daily for 21 days following the first injection of goserelin. Participants continued on treatment until disease progression or unacceptable toxicity.

Enrollment: 35 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

• Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive

• Premenopausal, defined as any of:

  1. Last menstrual period within 3 months, or
  2. Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or,
  3. If tamoxifen administered within the past 3 months, plasma estradiol must be in the premenopausal range

• Either positive estrogen and/or progesterone receptor determination by Immunohistochemistry (IHC) or competitive binding assay on metastatic disease, or if not performed on their metastatic disease a positive result on their primary breast cancer specimen.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

• Granulocytes > 1500/mm^3

• Platelets > 100,000/mm^3

• Serum glutamic oxaloacetic transaminase (SGOT) < 2.5 x upper limit of normal

• Total bilirubin < 1.5 mg/dL

• May have received irradiation to bony sites of disease for pain control or for prevention of fracture. The irradiated site(s) will NOT be evaluable for disease response.

• Must be using effective contraception or not be of childbearing potential

• Signed written informed consent

INCLUSION CRITERIA

• Active, unresolved infection
• Active malignancy other than breast cancer, in situ carcinoma of the cervix, or non-melanomatous skin cancers in the past 5 years
• Prior treatment with an aromatase inhibitor or inactivator
• Prior treatment with an luteinizing hormone-releasing hormone (LH/RH) agonist/antagonist
• Adjuvant chemotherapy within 6 months of study entry.
• Received chemotherapy or hormonal therapy in the 3 weeks prior to enrollment
• Central nervous system metastasis
• Lymphangitic pulmonary metastasis
• Pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Anastrozole + Goserelin

Experimental group

Description:

Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily. No dose attenuation or escalation was allowed for either goserelin or anastrozole.

Treatment:

Drug: Goserelin (Zoladex)

Drug: Anastrozole (Arimidex)