RecruitingER-Positive HER2-Negative Breast Cancer

A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer

Eligible age

18–130 yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.

Sponsor: AstraZeneca

You may qualify if…

✓ 1. Capable of giving signed informed consent.
✓ 2. Female or male, must be ≥ 18 years or as per locally allowed age limit for screening.
✓ Type of Participant and Disease Characteristics
✓ 3. Histologically or cytologically documented diagnosis of ER+, HER2- BC based on local laboratory results and who are not amenable to resection or radiation therapy with curative intent.
✓ 4. Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
✓ 5. De novo Stage 4 disease, or recurrence from early CD stage breast cancer after having received standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation.
✓ 6. ECOG performance status of 0 or 1.
✓ 7. Adequate organ and marrow function. Sex and Contraceptive/Barrier Requirements

You may not qualify if…

✕ 1. Participants who are not clinically indicated for endocrine therapy in combination with the CDK4/6 inhibitor ribociclib.
✕ 2. No evidence of advanced inoperable disease, or bone only disease with sclerotic/osteoblastic bone lesions only per standard of care imaging.
✕ 3. Have advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term, and/or pulmonary lymphangitis.
✕ 4. Persistent treatment-induced non-haematological toxicities (CTCAE Grade \> 2).
✕ 5. Known active infection including tuberculosis HBV and HCV.
✕ 6. Known to have tested positive for HIV. Participants with HIV may be enrolled if they fulfil the criteria recommended by FDA and ASCO guidelines.
✕ 7. Any clinically important abnormalities in heart conduction patterns; participants with pacemakers or medically controlled atrial fibrillation are not excluded.
✕ 8. Ongoing symptomatic hypotension.