Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Goserelin · 1 trial · 4 indications
* Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \[Eur J Ca 45:228-247, 2009\]. * In each RECIST response category Oncotype DX scores will be summarized with mean, standard deviation, minimum, 1st, 2nd (median) and 3rd quartiles, and maximum values. OncotypeDx scores range from 0 to 100, with scores \<18 indicating low risk.
| Arm | Type | Description |
|---|---|---|
| Endocrine therapy alone | EXPERIMENTAL | * Neoadjuvant endocrine therapy will be given at the discretion of the treating physician as directed by the package insert and could include the following: goserelin, anastrozole, letrozole, exemestane, fulvestrant, or tamoxifen * Frequency of office visits will be decided by the treating physician but must occur no less frequently than every 3 to 6 months for tumor assessment * After 6 months and after 12 months, patients will be assessed; patients who progress will have standard care recommended , and at any point a patient can opt to receive standard care even if she has not progressed on neoadjuvant endocrine therapy * Information on quality of life will be collected at baseline, Year 1, and Year 2 by the FACT-B questionnaire * Archival tissue will be collected and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score predicts chemotherapy benefit and indicates the 10-year risk of recurrence (will not be used to determine treatment) |
| Name | Type | Description |
|---|---|---|
| FACT-B | BEHAVIORAL | The FACT-B (Version 4) is a 37-item measure that contains the four general subscales along with the Breast Cancer-Specific subscale that assesses symptoms/concerns of particular relevance to breast cancer (e.g., body image, arm swelling and tenderness). |
| Goserelin | DRUG | - |
| Anastrozole | DRUG | - |
| Exemestane | DRUG | - |
| Fulvestrant | DRUG | - |
| Tamoxifen | DRUG | - |
| Archived tissue collection | OTHER | - |
Inclusion Criteria: * Newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0. * Disease must be ER+ and HER2-. * Ki67 score/proliferative index ≤ 30% or low to intermediate mitotic index * Measurable disease defined as lesions th...
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Goserelin is being studied for use in breast cancer, specifically in elderly patients with estrogen receptor positive operable breast cancer and a low recurrence score. It is an investigational endocrine treatment being evaluated in a Phase 2 clinical trial.
Goserelin is being developed by Exact Sciences Corporation, a company traded on NASDAQ under the ticker EXAS. The company is conducting a Phase 2 clinical trial of Goserelin in breast cancer.
Goserelin is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is recruiting participants with estrogen receptor positive operable breast cancer.
Goserelin is being studied in a Phase 2 clinical trial with the identifier NCT02476786. The trial is titled "Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score" and is recruiting 50 female patients aged 70 years and older in the United States.
Yes, Goserelin is classified as a small molecule therapeutic. It is being investigated as an endocrine treatment for breast cancer in a Phase 2 clinical trial.