ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Neg… (NCT07423611) | Clinical Trial Compass
Not Yet RecruitingPhase 2
ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer
China388 participantsStarted 2026-10-01
Plain-language summary
This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus ET in patients with circulating tumor DNA (ctDNA)-negative, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
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
. Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure
. Patient is female with known menopausal status at the time of randomization
. Patient is ≥ 18 and ≤70 years-old at the time of PICF signature.
. Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis
. Patient has breast cancer that is positive for ER and/or PgR as determined on the most recently analyzed tissue sample
. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample).
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
. Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:
. histological Grade 3,
Exclusion criteria
. Prior neoadjuvant or adjuvant systemic treatment (including chemotherapy, targeted therapy, or endocrine therapy) for breast cancer
. Bilateral breast cancer
. Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery
. Patient has other active malignancies within the past 2 years
. Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial
. Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
. Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to a NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0 Grade ≤ 1 at day of randomization
. Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial