BridgeMD
A Window-of-Opportunity study of hormone therapy in premenopausal women with ER-positive/HER2-negative early breast cancer.
EU CTIS ID: 2022-503013-32-00
What this study is testing
1. To determine if 4 weeks of giredestrant plus triptorelin provides greater anti-proliferative activity than anastrozole plus triptorelin among premenopausal patients with ER-positive/HER2-negative operable invasive breast cancer. 2. To determine if 4 weeks of giredestrant without triptorelin provides anti-proliferative activity that is similar (non-inferior) to giredestrant plus triptorelin among premenopausal patients with ER-positive/HER2-negative operable invasive breast cancer.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Premenopausal women age ≥18 years, premenopausal status defined as: o Estradiol (E2) in the premenopausal range (according to institution parameters) or o Patient has been menstruating regularly during the 6 months prior to screening and has not used any form of hormonal contraception or any other hormonal treatments during this time. • Histologically confirmed, operable invasive breast carcinoma. • Eligible for upfront breast conservative surgery or upfront mastectomy: stage I, stage II or operable stage III (excludes T4) o Tumor size must be ≥1.0 cm o Multicentric and multifocal tumors and bilateral breast cancers are allowed but investigators must ensure the same tumor foci is biopsied pre-treatment and post-treatment (e.g., via clipping of the biopsied tumor foci). o Patients with distant metastatic disease are not eligible. • Documented estrogen receptor (ER)-positive tumor in accordance to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, assessed locally and defined as ≥1% of tumor cells stained positive. • Documented human epidermal growth factor receptor-2 (HER2)-negative tumor in accordance to 2018 ASCO/CAP guidelines, as determined per local assessment. • Ki-67 ≥10% in diagnostic biopsy as determined per local assessment. • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. • Resting heart rate ≥40 bpm. • Normal hematologic, renal and liver function • Negative serum or urine beta HCG pregnancy test within 5 weeks prior to randomization. • Pregnancy test will be repeated on day 1, before the first dose of WOO treatment. Women of childbearing potential must use highly effective contraceptive methods during the treatment period and for 10 days after the final dose. • Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization. • The patient agrees to the submission of tumor (diagnostic core biopsy and re-biopsy) and blood samples for Central Pathology Review (CPR) and for translational studies as part of this protocol. Note: CPR on the primary tumor is mandatory for this trial, but patients will be evaluated for eligibility according to tumor characteristics as determined by the local pathologist. Both the diagnostic breast core biopsy specimen and the specimen from the re-biopsy or from the breast surgery after the WOO treatment is completed must be submitted for CPR, which will be done by the IBCSG Central Pathology Office in Milan, Italy.
You likely can't join if
- • Stage IV (metastatic) breast cancer. • Inflammatory breast cancer (cT4d). • Previous systemic or local treatment for the primary breast cancer currently under investigation. • Received any GnRH/LHRH analog within 12 months prior to randomization. • Major surgery within 4 weeks prior to randomization. • Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis. • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. • History of documented hemorrhagic diathesis, coagulopathy, or thromboembolism. • Active cardiac disease or history of cardiac dysfunction. • History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias. • Current treatment with medications that are well known to prolong the QT interval. • Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment. • Known issues with swallowing oral medication. • Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery including gastric resection. • Serious infection requiring oral or IV antibiotics. • Any active tumor of non-breast-cancer histology. • Women who are pregnant or in the period of lactating. • Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
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, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. 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 EU CTIS; the study team decides eligibility.