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

NCT ID: NCT00186121

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31
• Study Completion Date: 2013-06-30

Brief Summary

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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anastrozole + Goserelin

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.

Group Type: EXPERIMENTAL

Anastrozole (Arimidex)

Intervention Type: DRUG

Anastrozole is a prescription hormonal treatment that helps fight breast cancer by lowering the amount of estrogen in the body. It is a non-steroidal aromatase inhibitor, which significantly lowers serum estradiol (estrogen) concentrations, without interfering with the formation of adrenal corticosteroids or aldosterone

Goserelin (Zoladex)

Intervention Type: DRUG

Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women

Interventions

Anastrozole (Arimidex)

Anastrozole is a prescription hormonal treatment that helps fight breast cancer by lowering the amount of estrogen in the body. It is a non-steroidal aromatase inhibitor, which significantly lowers serum estradiol (estrogen) concentrations, without interfering with the formation of adrenal corticosteroids or aldosterone

Intervention Type: DRUG

Goserelin (Zoladex)

Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women

Intervention Type: DRUG

Other Intervention Names

Arimidex; Zoladex

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Melinda Telli

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melinda Telli, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Carlson RW, Theriault R, Schurman CM, Rivera E, Chung CT, Phan SC, Arun B, Dice K, Chiv VY, Green M, Valero V. Phase II trial of anastrozole plus goserelin in the treatment of hormone receptor-positive, metastatic carcinoma of the breast in premenopausal women. J Clin Oncol. 2010 Sep 1;28(25):3917-21. doi: 10.1200/JCO.2009.24.9565. Epub 2010 Aug 2.

Reference Type: RESULT

PMID: 20679610 (View on PubMed)

Other Identifiers

75597

Identifier Type: OTHER

Identifier Source: secondary_id

BRSMTS0001

Identifier Type: OTHER

Identifier Source: secondary_id

1033VS0012

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-13429

Identifier Type: -

Identifier Source: org_study_id