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

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ClinicalTrials.gov Identifier: NCT00186121
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Melinda Telli, Stanford University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Anastrozole (Arimidex) Drug: Goserelin (Zoladex) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor Positive, Metastatic Carcinoma of the Breast in Premenopausal Women
Study Start Date : October 2000
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.
Drug: 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
Other Name: Arimidex

Drug: Goserelin (Zoladex)
Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women
Other Name: Zoladex




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186121


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
AstraZeneca
Investigators
Principal Investigator: Melinda Telli, MD Stanford University

Publications of Results:
Responsible Party: Melinda Telli, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00186121     History of Changes
Other Study ID Numbers: IRB-13429
75597 ( Other Identifier: Stanford IRB alternate )
BRSMTS0001 ( Other Identifier: OnCore )
1033VS0012 ( Other Identifier: alternate )
First Posted: September 16, 2005    Key Record Dates
Results First Posted: April 5, 2018
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estradiol
Anastrozole
Goserelin
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists