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

NCT00186121 | Completed Phase 2 Results DMC

• 4 other identifiers: IRB-1342975597BRSMTS00011033VS0012
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR was determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rates. * CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks. * PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion. All measurements by ruler or calipers.

  3 months

Secondary Outcomes (6)

• Clinical Benefit Rate

  6 months

• Response Rates

  6 months

• Time-to-Progression (TTP)

  up to 63 months

• Overall Survival (OS)

  up to 63 months

• Estradiol Suppression

  6 months

Study Arms (1)

Anastrozole + Goserelin

EXPERIMENTAL

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.

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

Interventions

Anastrozole (Arimidex) 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

Also known as: Arimidex

Anastrozole + Goserelin

Goserelin (Zoladex) DRUG

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

Also known as: Zoladex

Anastrozole + Goserelin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive
• Premenopausal, defined as any of:
• Last menstrual period within 3 months, or
• Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or,
• 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

Sponsors & Collaborators

• Stanford University: lead
• AstraZeneca: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 20679610 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Melinda Telli, MD
• Organization: Stanford University Medical Center

mtelli@stanford.edu

650-724-9533

Study Officials

• Melinda Telli, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: October 1, 2000
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 7, 2019
• Results First Posted: April 5, 2018

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)