Breast CancerPhase 1/2NCT07164976
Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
A Phase 1/2 study testing Ribociclib 400mg and Ribociclib 600mg in people with Breast Cancer, run by Nagoya City University at 1 site in Japan.
Trial summary
This document outlines an investigator-initiated Phase Ib/II clinical trial in Japan, focusing on the combination therapy of ribociclib and anastrozole for patients with hormone receptor-positive (HR-positive), HER2-negative metastatic or recurrent breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ribociclib 400mg and Ribociclib 600mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteJapan
- Study dates
- 1 Oct 2025to 1 Apr 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Nagoya City University
Nagoya
Kazuki Nozawa, MD, +81-52-853-8020, ribociclib_IIS_CMIC@cmic.co.jp
About this study
Official title: Phase Ib/II Trial of Ribociclib Plus Anastrozole in Patients With Hormone Receptor-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer
This document outlines an investigator-initiated Phase Ib/II clinical trial in Japan, focusing on the combination therapy of ribociclib and anastrozole for patients with hormone receptor-positive (HR-positive), HER2-negative metastatic or recurrent breast cancer. The trial aims to evaluate the efficacy (specifically, overall response rate) and safety of this combination in the Japanese patient population. Nagoya City University is the sponsor of this trial, with funding provided by Novartis Pharma K.K..
Study Design and Endpoints: The trial is structured into two parts:
- Phase Ib: The primary endpoint for this phase is tolerability, which is assessed by dose-limiting toxicities (DLT). Secondary endpoints include pharmacokinetics (PK) of the drugs, as well as the incidence of adverse events (AE) and serious adverse events (SAE).
- Phase II: The primary endpoint for Phase II is the Overall Response Rate (ORR), which will be determined by a blinded central imaging review based on RECIST version 1.1 criteria. Secondary endpoints encompass PK (for the initial 20 patients), ORR as assessed by the investigator, progression-free survival (PFS), overall survival (OS), and the overall incidence of adverse events
- Conditions
- Breast Cancer
- Being tested
- Ribociclib 400mg, Ribociclib 600mg
- Keywords
- breast cancer, ribociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ribociclib 400mgDrug
phase 1b cohort 1
Ribociclib 600mgDrug
Phase 1b cohort 2
Ribociclib 600mgDrug
phase 2
| Study group | Role | What they receive |
|---|---|---|
| phase 1b cohort 1 | Experimental | phase 1b cohort 1 Receives: Drug: Ribociclib 400mg |
| phase 1b cohort 2 | Experimental | phase 1b cohort 2 Receives: Drug: Ribociclib 600mg |
| phase 2 part | Experimental | Not described Receives: Drug: Ribociclib 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b part: Dose Limiting Toxicity
Measured: From enrollment to the end of treatment at 4 weeks
Phase 2 part: Overall response rate
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (5)
Phase 1b part: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From enrollment to the end of treatment at 4 weeks
Phase 1b part: Peak Plasma Concentration (Cmax)
Measured: From enrollment to the end of treatment at 4 weeks
Phase 2 part: Overall Response Rate
Measured: From enrollment to the end of treatment at 24 weeks
Phase 2 part: PFS
Measured: Time Frame: From enrollment to the end of treatment at 24 weeks
Phase 2 part: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Oct 2025
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagoya City University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Kazuki Nozawa, Nagoya City University
- Investigators
- Hiroji Iwata, MD. PhD., Study chair, Nagoya City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164976
- Sponsor's protocol ID
- NCU-002-Ribo(M)
- Status last verified
- Apr 2026
- First submitted
- 23 Aug 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Trial of Ribociclib Plus Anastrozole in Patients With Hormone Receptor-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer
- ClinicalTrials.gov ID
- NCT07164976
- Acronym / sponsor ID
- NCU-002-Ribo(M)
- Conditions
- Breast Cancer
- Keywords
- breast cancer, ribociclib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Nagoya City UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This document outlines an investigator-initiated Phase Ib/II clinical trial in Japan, focusing on the combination therapy of ribociclib and anastrozole for patients with hormone receptor-positive (HR-positive), HER2-negative metastatic or recurrent breast cancer. The trial aims to evaluate the efficacy (specifically, overall response rate) and safety of this combination in the Japanese patient population. Nagoya City University is the sponsor of this trial, with funding provided by Novartis Pharma K.K..
Study Design and Endpoints: The trial is structured into two parts:
- Phase Ib: The primary endpoint for this phase is tolerability, which is assessed by dose-limiting toxicities (DLT). Secondary endpoints include pharmacokinetics (PK) of the drugs, as well as the incidence of adverse events (AE) and serious adverse events (SAE).
- Phase II: The primary endpoint for Phase II is the Overall Response Rate (ORR), which will be determined by a blinded central imaging review based on RECIST version 1.1 criteria. Secondary endpoints encompass PK (for the initial 20 patients), ORR as assessed by the investigator, progression-free survival (PFS), overall survival (OS), and the overall incidence of adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| phase 1b cohort 1 | Experimental | Drug: Ribociclib 400mgphase 1b cohort 1 |
| phase 1b cohort 2 | Experimental | Drug: Ribociclib 600mgphase 1b cohort 2 |
| phase 2 part | Experimental | Drug: Ribociclib 600mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ribociclib 400mgphase 1b cohort 1 | Drug | phase 1b cohort 1 |
| Ribociclib 600mgPhase 1b cohort 2 | Drug | phase 1b cohort 2 |
| Ribociclib 600mgphase 2 | Drug | phase 2 part |
Primary outcome
Phase 1b part: Dose Limiting Toxicity
Time frame: From enrollment to the end of treatment at 4 weeks
Phase 2 part: Overall response rate
Time frame: From enrollment to the end of treatment at 24 weeks
5 secondary outcomes
Phase 1b part: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From enrollment to the end of treatment at 4 weeks
Phase 1b part: Peak Plasma Concentration (Cmax)
Time frame: From enrollment to the end of treatment at 4 weeks
Phase 2 part: Overall Response Rate
Time frame: From enrollment to the end of treatment at 24 weeks
Phase 2 part: PFS
Time frame: Time Frame: From enrollment to the end of treatment at 24 weeks
Phase 2 part: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From enrollment to the end of treatment at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hiroji Iwata, MD. PhD. study chair
Nagoya City University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ribociclib 400mg and Ribociclib 600mg in people with Breast Cancer, run by Nagoya City University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kazuki Nozawa (+81-52-853-8020, ribociclib_IIS_CMIC@cmic.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b part: Dose Limiting Toxicity (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.