BridgeMD
New treatment option for Anatomic Stage I Breast Cancer AJCC v8
Official title Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial
ClinicalTrials.gov ID: NCT07158021
What this study is testing
What is Goserelin?
Goserelin is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for anatomic stage i breast cancer ajcc v8.
Also referred to as ICI-118630.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female subject aged ≥ 18 years
- Pre- or peri-menopausal patient, who had (1) menses either within the 12 months prior to or since breast cancer diagnosis or (2) estradiol...
- Planning to take GnRHa therapy in combination with oral endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment...
- Not planning bilateral salpingo-oophorectomy during the 6-month study duration
- Completion of chemotherapy, if given. Concurrent use of trastuzumab, pertuzumab, bisphosphonate therapy, poly adenosine diphosphate-ribose polymerase...
You likely can't join if
- Prior bilateral salpingo-oophorectomy
- Known to be pregnant or breastfeeding (negative pregnancy test will be confirmed prior to study treatment initiation)
- Concomitant use of systemic or transdermal estrogen products
- Known allergy or hypersensitivity to goserelin or leuprolide, or any of the excipients in the medications
- Unable to take oral medications
- Any medical condition that would interfere with the absorption of endocrine therapy. Prior gastric bypass is permitted
See the full eligibility criteria
- Female subject aged ≥ 18 years
- Pre- or peri-menopausal patient, who had (1) menses either within the 12 months prior to or since breast cancer diagnosis or (2) estradiol concentration above the postmenopausal range per institutional laboratory...
- Planning to take GnRHa therapy in combination with oral endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment of stage 1-3 breast cancer or for treatment of metastatic breast...
- Not planning bilateral salpingo-oophorectomy during the 6-month study duration
- Completion of chemotherapy, if given. Concurrent use of trastuzumab, pertuzumab, bisphosphonate therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy, cyclin D kinase 4/6 (CDK4/6) inhibitor...
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
- Prior bilateral salpingo-oophorectomy
- Known to be pregnant or breastfeeding (negative pregnancy test will be confirmed prior to study treatment initiation)
- Concomitant use of systemic or transdermal estrogen products
- Known allergy or hypersensitivity to goserelin or leuprolide, or any of the excipients in the medications
- Unable to take oral medications
- Any medical condition that would interfere with the absorption of endocrine therapy. Prior gastric bypass is permitted
- Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or how well it works assessment of the...
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.