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| ID | Type | Description | Link |
|---|---|---|---|
| 75597 | Other Identifier | Stanford IRB alternate | |
| BRSMTS0001 | Other Identifier | OnCore | |
| 1033VS0012 | Other Identifier | alternate |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rates.
All measurements by ruler or calipers. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
All measurements by ruler or calipers. |
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INCLUSION CRITERIA
Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive
Premenopausal, defined as any of:
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
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| Name | Affiliation | Role |
|---|---|---|
| Melinda Telli, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20679610 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | ORR was determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rates.
All measurements by ruler or calipers. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 months |
|
Up to 63 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flush | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melinda Telli, MD | Stanford University Medical Center | 650-724-9533 | mtelli@stanford.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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|
|
| Goserelin (Zoladex) | Drug | Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women |
|
|
| 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.
All measurements by ruler or calipers. | 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. | up to 63 months |
| Overall Survival (OS) | Overall survival (OS) was assessed as the median observed in the participants receiving goserelin followed by anastrozole. | 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. | 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. | 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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.
All measurements by ruler or calipers. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
|
| Secondary | 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.
All measurements by ruler or calipers. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | months | up to 63 months |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival (OS) was assessed as the median observed in the participants receiving goserelin followed by anastrozole. | Posted | Median | Full Range | months | up to 63 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | pg/mL estradiol | 6 months |
|
|
|
| Secondary | 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. | Posted | Number | Serious Adverse Events (SAEs) | 6 months |
|
|
|
| 15 |
| 32 |
| 0 |
| 32 |
| 32 |
| 32 |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Vaginal dryness | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Mood alteration | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| General disorders, other: Increased Sweating | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Edema | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
|
| Pain | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Weight loss | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
|
| Flu-like symptoms | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Gastrointestinal disorders - Other, cramping | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Gastrointestinal disorders - Other, Heart burn | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Rectal bleeding | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Watering eyes | Eye disorders | CTCAE v4.0 | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE v4.0 | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| Title | Measurements |
|---|---|
|
| Mean at 3 months treatment |
|
| Mean at 6 months treatment |
|