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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00186121 (opens ClinicalTrials.gov in a new tab)Other idIRB-13429Other id75597Other idBRSMTS0001Other id1033VS0012
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Overview

Status
Completed
Phase
Phase 2
Enrollment
35 participants (actual)
Sponsor
Stanford University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Oct 2000
Primary completion
May 2013
Completion
Jun 2013
First posted
16 Sept 2005 (estimated)
Last update posted
7 Oct 2019
Conditions
Breast Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200020052010
  1. Ph 2

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

    NCT00186121

    Oct 2000 to Jun 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Anastrozole (Arimidex)Drug
  • Goserelin (Zoladex)Drug

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Objective Response Rate (ORR)

    Time frame · 3 months

    Registry description

    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(6)

  1. Clinical Benefit Rate

    Time frame · 6 months

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

  5. Estradiol Suppression

    Time frame · 6 months

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 3 months

Objective Response Rate (ORR)

GroupValue (percentage of participants)
Anastrozole + Goserelin37.5
Secondary and other outcome results(6)
Secondary outcomeNumber· 6 months

Clinical Benefit Rate

GroupValue (percentage of participants)
Anastrozole + Goserelin71.9
Secondary outcomeCount of participants· 6 months

Response Rates

GroupValue (Participants)
Anastrozole + Goserelin1
Secondary outcomeMedian· up to 63 months

Time-to-Progression (TTP)

GroupValue (months)
Anastrozole + Goserelin8.3
Secondary outcomeMedian· up to 63 months

Overall Survival (OS)

GroupValue (months)
Anastrozole + GoserelinNA
Secondary outcomeMean· 6 months

Estradiol Suppression

GroupValue (pg/mL estradiol)Spread
Anastrozole + Goserelin74.7NA
Secondary outcomeNumber· 6 months

Serious Adverse Events

GroupValue (Serious Adverse Events (SAEs))
Anastrozole + Goserelin0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Anastrozole + GoserelinParticipants 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.15 / 320 / 3232 / 32

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2010

Phase II trial of anastrozole plus goserelin in the treatment of hormone receptor-positive, metastatic carcinoma of the breast in premenopausal women.

Carlson et al. 2010Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 57

PMID 20679610DOI 10.1200/jco.2009.24.9565PUB-20679610

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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