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OncoMatch/Clinical Trials/NCT07085767

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

Is NCT07085767 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Palazestrant and Ribociclib for breast cancer.

Phase 3RecruitingOlema Pharmaceuticals, Inc.NCT07085767Data as of Jun 2026Location: International · 10 countries

Treatment: Palazestrant · Ribociclib · LetrozoleThis phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Ribociclib

Endocrine / hormonal

PalazestrantLetrozole

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) negative

Required: ESR1 positive

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic anti-cancer therapy

Cannot have received: endocrine therapy (fulvestrant, elacestrant)

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Clinical Trial Site · Denver, Colorado
  • Clinical Trial Site · Ames, Iowa
  • Clinical Trial Site · Scarborough, Maine
  • Clinical Trial Site · Kansas City, Missouri
  • Clinical Trial Site · Santa Fe, New Mexico

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07085767 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ERBB2?

Yes, ERBB2 negative is a required biomarker for enrollment.

Does this trial require ESR1?

Yes, ESR1 positive is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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