Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and … (NCT05664893) | Clinical Trial Compass
WithdrawnPhase 1/2
Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and Hypofractionated Radiotherapy in Breast Cancer, With Positive Hormone Receptors and Negative HER2 Status, in Newly Diagnosed, Not Immediately Operable Elderly Patient (CALHYS)
Stopped: Sponsor decision due to recruitment default
France0Started 2023-06-26
Plain-language summary
Women aged 70 years or older, newly diagnosed for locally advanced unilateral breast cancer, with a histological diagnosis of invasive mammary carcinoma, positive hormone receptors, HER2 status Negative, not immediately operable (stage of disease, comorbidities or refusal of surgery) with tumor in place, with indication of treatment with hormone therapy and hypofractionated radiotherapy, not eligible for neoadjuvant chemotherapy and without major comorbidity contraindicating the proposed treatment regimen.
Who can participate
Age range
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
. Written informed consent must be obtained prior to any screening procedures;
. Women ≥ 70 years old at the time of signing informed consent;
. Have a performance status of 0 to 2 on the ECOG Performance Scale ;
. Newly diagnosed for non-metastatic unilateral breast cancer;
. Histological diagnosis of invasive mammary carcinoma, positive hormone receptors, HER2 status Negative defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample;
. Not immediately operable (stage of disease, comorbidities or wish to avoid surgery) with tumor in place;
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.
What they're measuring
1
Phase I : determination of Maximal Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) of Ribociclib
Timeframe: Phase I : during the 8 weeks of radiotherapy concomitant with the Ribociclib and hormone therapy and during the 3 months of post-radiotherapy follow-up.
2
Phase II : evaluation of the efficacy of Ribociclib in association with hormone therapy and hypofractionated radiotherapy
. Measurable disease based on RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is a clear sign of progression since the irradiation).
. Demonstrate adequate organ functions:
Exclusion criteria
. Patient eligible to resection surgery and wish to proceed with the surgery;
. Patient eligible to neoadjuvant chemotherapy;
. Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition);
. Concomitant bilateral breast cancer;
. Previous treatment, in the 2 years before inclusion, by chemotherapy, hormone therapy (more than 6 months before study registration), thoracic surgery or radiotherapy for a malignant tumor;
. Tumor in previously irradiated territory;
. Patient has received any CDK4/6 inhibitor;
. Patient with a known hypersensitivity to any of the excipients of Ribociclib and/or hormono therapy (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy);