Ribociclib plus anastrozole for HR-positive, HER2-negative metastatic breast cancer
Official title: Phase Ib/II Trial of Ribociclib Plus Anastrozole in Patients With Hormone Receptor-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer
Run by Nagoya City University · NCT07164976 · Data updated 2026-11-12
This trial will test whether adding ribociclib to anastrozole helps people in Japan with HR-positive, HER2-negative metastatic or recurrent breast cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 86 (estimated) |
| Sponsor | Nagoya City University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nagoya) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | September 1, 2029 |
| Study ends | April 1, 2030 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07164976 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) in Japan with histologically confirmed HR-positive, HER2-negative unresectable recurrent or metastatic breast cancer, ECOG 0–1, suitable for endocrine therapy, and without prior CDK4/6 inhibitor or metastatic systemic therapy exposure.
✕Probably not a fit
Patients with symptomatic visceral metastases, those unsuitable for endocrine therapy, those previously treated with CDK4/6 inhibitors, or with recent adjuvant endocrine therapy are unlikely to benefit from joining this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase Ib/II trial in Japan combines the CDK4/6 inhibitor ribociclib with the aromatase inhibitor anastrozole for patients with HR-positive, HER2-negative metastatic or recurrent breast cancer. Phase Ib evaluates tolerability and dose-limiting toxicities and collects pharmacokinetic data across ribociclib 400 mg and 600 mg dose cohorts. Phase II measures overall response rate determined by blinded central imaging review using RECIST criteria to estimate anti-tumor activity. Safety, adverse events, and serious adverse events are monitored throughout the study.
Why it matters
Potential benefit: If successful, the combination could improve tumor responses and extend the time patients can be treated with endocrine-based therapy before needing chemotherapy.
How similar studies have gone: Large international trials combining ribociclib with aromatase inhibitors have shown improved progression-free survival, so the approach is established though this trial focuses on dose, tolerability, and response in Japanese patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed invasive breast cancer. * Hormone receptor-positive (ER positive and/or PgR positive) and HER2-negative disease: ER positive: ≥1% positive cells or Allred score ≥3. PgR positive: ≥1% positive cells or Allred score ≥3. HER2 negative: IHC 0, 1+, or 2+ with no ISH amplification. * Advanced or recurrent breast cancer (unresectable, recurrent, or Stage IV). * Age ≥18 years at registration. * ECOG Performance Status of 0-1. Exclusion Criteria: * Symptomatic visceral metastases or deemed unsuitable for endocrine therapy. * Prior endocrine therapy or chemotherapy for metastatic/recurrent disease. * Prior CDK4/6 inhibitor exposure (perioperative or metastatic setting). * Adjuvant endocrine therapy within 35 days before study start. * Active malignancy other than allowed exceptions (e.g., resected skin cancers, ≥5-year disease-free cancers). * Hypersensitivity to ribociclib, anastrozole, or their components (including soy/peanut allergy, sugar intolerances).
Where it's running
-
Nagoya City University
Nagoya, Japan Recruiting
Study contacts
- Study coordinator: Kazuki Nozawa
- Email: ribociclib_IIS_CMIC@cmic.co.jp
- Phone: +81-52-853-8020
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.