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Completed

NCT Number: NCT00186121

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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

Other names: Arimidex

Goserelin (Zoladex)

Drug

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

Other names: Zoladex

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 3 months

    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.

Secondary outcomes

  1. Clinical Benefit Rate

    Time frame: 6 months

    The overall clinical benefit rate of goserelin followed by anastrozole was evaluated, as determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rate + Stable Disease (SD) rate.

    • 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.
    • SD = No significant change in measurable or evaluable disease for at least 4 weeks.

    All measurements by ruler or calipers.

  2. Response Rates

    Time frame: 6 months

    The numbers of participants with metastatic breast cancer experiencing Complete Response (CR); Partial Response (PR); or Stable Disease (SD) after treatment with goserelin followed by anastrozole are reported.

    • 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.
    • SD = No significant change in measurable or evaluable disease for at least 4 weeks.

    All measurements by ruler or calipers.

  3. Time-to-Progression (TTP)

    Time frame: up to 63 months

    Time-to-progression (TTP) was assessed as the median observed in the participant group.

    Progression of disease was considered, per protocol, to be ≤ 25% increase in the area of any malignant lesion greater than 2 square cm, or ≤ 25% increase in the sum of the products of the longest perpendicular diameters of individual lesions in a given organ, when compared to baseline values or after therapeutic response.

  4. Overall Survival (OS)

    Time frame: up to 63 months

    Overall survival (OS) was assessed as the median observed in the participants receiving goserelin followed by anastrozole.

  5. Estradiol Suppression

    Time frame: 6 months

    Plasma estradiol determinations were performed at baseline, 1 month, 3 months, and 6 months using the Coat-A-Count Estradiol competitive binding assay system, which has a calibrated range for estradiol of 20 to 3,600 pg/mL with an analytical sensitivity of 10 pg/mL.

  6. Serious Adverse Events

    Time frame: 6 months

    The toxicity of the treatment regimen of goserelin followed by anastrozole is estimated by the rate of Serious Adverse Events (SAEs) that occurred during the course of the study.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor Positive, Metastatic Carcinoma of the Breast in Premenopausal Women

Important dates

Study start
2000
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2005
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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