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)

Conditions

• HER2 Negative Breast Cancer Not Immediately Operated

Eligibility Criteria

Sex

FEMALE

Age

70 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ribociclib Oral Tablet — DRUG
  600mg per day during registration phase (3 cycles); de-escalation phase (600 to 200mg per day associated to radiotherapy) during 3 other cycles; maintenance phase until 24 months of treatment in total (600mg per day). All over th etimme, hormonotherapy is received in concomitance

Study Details

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.

Key Dates

Start date

Jun 26, 2023

Status verified

Apr 2026

Primary completion

Mar 26, 2026

Completion

Mar 26, 2026

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Principal arm
  registration phase : 3 cycles of 600mg per day of ribociclib Treatment phase : 3 cycles of dose de-escalation of ribociclib (600 or 400 or 200mg per day) Maintenance phase : 600mg per day of ribociclib until 24months of total treatment

Primary Outcome Measure

Phase I : determination of Maximal Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) of Ribociclib [ Time Frame: 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. ]