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 range70 Years

SexFEMALE

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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;
✓. 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

What they're measuring

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.

Phase II : evaluation of the efficacy of Ribociclib in association with hormone therapy and hypofractionated radiotherapy

Timeframe: Phase II : at 24-months

Trial details

NCT IDNCT05664893

SponsorCentre Antoine Lacassagne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-26

View on ClinicalTrials.gov More HER2 Negative Breast Cancer Not Immediately Operated trials