Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer (NCT07102940) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer
50 participantsStarted 2026-09-01
Plain-language summary
The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment. This is a prospective single arm interventional trial in patients with early-stage HR+/HER2 -ve breast cancer (Stage I-III) who are eligible for neoadjuvant chemotherapy (NAC). Enrolled patients will be treated with single agent efti for 3 weeks and then start NAC in combination with efti. There are 2 standard NAC usually used and will be determined by treating physician prior to starting on this trial.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have histologically documented HR+/HER2 neg (defined as ER expression \>10% by IHC and/or PR expression \> 10% by IHC and HER2 0 or 1+ or 2+ by IHC or FISH ratio \<2 or HER2 gene copy number of \<6).
* Clinical early-stage breast cancer (Stage I-III) and a candidate for NAC.
* Be informed of the investigational nature of the trial and all pertinent aspects of the trial.
* Have ECOG performance status of 0-2.
* Have the ability to understand and the willingness to sign a written informed -consent document in accordance with institutional and federal guidelines.
* Be ≥ 21 years of age.
* Have serum creatinine \< 1.5 x institutional upper limit of normal (IULN) or a calculated creatinine clearance ≥ 30ml/min (calculated by Cockcroft Gault equation), bilirubin ≤ 2.0, and an SGOT/SGPT/alkaline phosphatase ≤ 2.0 x IULN.
* Have adequate bone marrow function (ANC \>1000/μL, Platelets \>100,000/ml, Hemoglobin \>10gm/dL).
* Women of childbearing potential or male patients of reproductive potential with female partners of childbearing potential must not consider getting pregnant and must avoid pregnancy during the trial and for at least 6 months after the last dose of trial treatment. Female and male patients of reproductive potential must practice highly effective methods of contraception with their partners, if of reproductive potential, during treatment and for 6 months following last dose of treatment with IP.
Exclusion Criteria:
* Receiving concurrent anti-…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing Efti combined with neoadjuvant chemotherapy before surgery — can you explain what Efti is and why adding it to standard chemo might matter for HR-positive, HER2-negative breast cancer specifically?
2The main thing this Phase 2 trial is measuring is pathological complete response, meaning whether any cancer cells remain after treatment — how meaningful is that goal for my type of breast cancer, and what does achieving or not achieving it typically mean for long-term outcomes?
3Since this trial is listed as 'not yet recruiting,' do you know when it might open, and would waiting to potentially enroll affect my treatment timeline or outcomes compared to starting standard neoadjuvant chemotherapy now?
4Phase 2 trials are still in relatively early stages of testing — given that, how much is already known about Efti's safety profile, and what kinds of side effects should I be prepared to discuss if I were to consider this study?
5For someone with Stage 1-3 HR-positive, HER2-negative breast cancer like mine, is standard neoadjuvant chemotherapy alone already a well-established path, and how would you weigh that against waiting for or enrolling in a trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment
Timeframe: From enrollment to the end of the study (5 years)