A Phase 2 interventional study of Anastrozole (Arimidex) and Goserelin (Zoladex) in Breast Cancer, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-10-07.
Sponsored by Stanford University · Phase 2, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 35 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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INCLUSION CRITERIA
Premenopausal, defined as any of:
INCLUSION CRITERIA
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)
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
Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women
Also known as: Zoladex
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.
Time frame: 3 months
Clinical Benefit Rate
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.
Time frame: 6 months
Response Rates
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.
Time frame: 6 months
Time-to-Progression (TTP)
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.
Time frame: up to 63 months
Overall Survival (OS)
Overall survival (OS) was assessed as the median observed in the participants receiving goserelin followed by anastrozole.
Time frame: up to 63 months
Estradiol Suppression
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.
Time frame: 6 months
Serious Adverse Events
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.
Time frame: 6 months
| Milestone | Anastrozole + Goserelin |
|---|---|
| Started | 35 |
| Completed | 32 |
| Not completed | 3 |
| Withdrew: Subject withdrawal (no treatment) | 1 |
| Withdrew: Underwent oophorectomy (no treatment) | 1 |
| Withdrew: Not eligible (no treatment) | 1 |
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.
| percentage of participants | Anastrozole + Goserelin |
|---|---|
| Objective Response Rate (ORR) | 37.5 (21 to 56) |
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.
| percentage of participants | Anastrozole + Goserelin |
|---|---|
| Clinical Benefit Rate | 71.9 (53 to 86) |
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.
| Participants | Anastrozole + Goserelin |
|---|---|
| Complete Response (CR) | 1 |
| Partial Response (PR) | 11 |
| Stable Disease (SD) | 11 |
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.
| months | Anastrozole + Goserelin |
|---|---|
| Time-to-Progression (TTP) | 8.3 (2.1 to NA) |
Overall survival (OS) was assessed as the median observed in the participants receiving goserelin followed by anastrozole.
| months | Anastrozole + Goserelin |
|---|---|
| Overall Survival (OS) | NA (11.1 to NA) |
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.
| pg/mL estradiol | Anastrozole + Goserelin |
|---|---|
| Mean at Baseline | 74.7 ± NA |
| Mean at 1 month treatment | 20.8 ± NA |
| Mean at 3 months treatment | 18.7 ± NA |
| Mean at 6 months treatment | 14.8 ± NA |
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.
| Serious Adverse Events (SAEs) | Anastrozole + Goserelin |
|---|---|
| Serious Adverse Events | 0 |
Collected over Up to 63 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anastrozole + Goserelin | 15/32 (46.9%) | 0/32 (0%) | 32/32 (100%) |
| Event | Anastrozole + Goserelin |
|---|---|
| Hot flushVascular disorders | 19/32 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 17/32 |
| FatigueGeneral disorders | 16/32 |
| HeadacheNervous system disorders | 10/32 |
| AlopeciaSkin and subcutaneous tissue disorders | 8/32 |
| NeuropathyNervous system disorders | 6/32 |
| Vaginal drynessReproductive system and breast disorders | 6/32 |
| ConstipationGastrointestinal disorders | 4/32 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/32 |
| DiarrheaGastrointestinal disorders | 4/32 |
| Age, Continuous(years) | Anastrozole + Goserelin |
|---|---|
| Mean | 43 (28 to 51) |
| Sex: Female, Male(Participants) | Anastrozole + Goserelin |
|---|---|
| Female | 32 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Anastrozole + Goserelin |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 31 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Anastrozole + Goserelin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 7 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
Plan to share: No
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