HR+/HER2- Breast CancerPhase 2NCT07130643
Efficacy and Safety of CDK4/6 Inhibitors Combined With Endocrine Therapy in HR+/HER2- Neoadjuvant Therapy for Early Breast Cancer
A Phase 2 study testing CDK4/6 inhibitors+Endocrine Therapy in people with HR+/HER2- Breast Cancer, run by Xinhong Wu, PhD at 1 site in China.
Trial summary
This is a single arm, open label, phase 2 trial aimed to investigate the effects and safety of neoadjuvant CDK4/6 inhibitors in combination with endocrine for HR+/HER2- breast cancer. A total of 40 patients with stage II-III HR+/HER2- breast cancer will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HR+/HER2- Breast Cancer
- What is being tested?
- CDK4/6 inhibitors+Endocrine Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2024to 20 Jun 2027
- Phase
- Phase 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥18 years old.
- 2. Premenopausal and postmenopausal women or men with stage II-III disease (multifocal and/or multifocal early invasive breast cancer) if all tumors on histopathological examination meet the pathological criteria for ER and/or PR > 10% and HER2- (HER2 expression of 0 or 1+ or 2+ and negative FISH test).
- 3.Patients had to have histologically confirmed ER and (or PR>10%, HER2 -, early-stage invasive disease.
- 4.Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, PD/SD according to tumor evaluation, old age, and basic diseases can not tolerate chemotherapy.
- 5. ECOG PS score 0-2.
- 6. Patients must be able and willing to swallow and retain oral medications.
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- 7. In premenopausal women, a serum or urine pregnancy test had to be negative within 14 days of enrollment or in women who had been amenorrhea for less than 12 months at enrollment.
- 8.Patients who had received neoadjuvant endocrine therapy were eligible if they were enrolled within 6 months of the initial histologic diagnosis and had completed no more than 2 months of neoadjuvant endocrine therapy.
- 9. Absolute neutrophil count ≥1500/µL, platelet ≥100000/mm3, hemoglobin ≥10g/dL
Who cannot join
- 1. Prior treatment with any CDK4/6 inhibitor.
- 2. Inflammatory or stage IV or bilateral breast cancer.
- 3. History of allergic reactions caused by chemical or biological components similar to CDK4/6 inhibitors.
- Patients who received any drugs or substances that were effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.
- 5. Uncontrolled coexisting medical conditions may limit adherence to study requirements.
- 6. Pregnant women with a negative pregnancy test within 14 days before admission or women of childbearing potential.
- 7. Patients with a history of any malignancy were not eligible.
- 8. Patients receiving endocrine therapy within 5 years before diagnosis of current malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-arm Exploratory Study of Efficacy and Safety of CDK4/6 Inhibitors Combined With Endocrine Therapy in HR+/HER2- Neoadjuvant Therapy for Early Breast Cancer
This is a single arm, open label, phase 2 trial aimed to investigate the effects and safety of neoadjuvant CDK4/6 inhibitors in combination with endocrine for HR+/HER2- breast cancer. A total of 40 patients with stage II-III HR+/HER2- breast cancer will be enrolled. Six 4-week cycles of adjuvant therapy will be administrated.Premenopausal or perimenopausal patients should combine ovarian function suppression, including bilateral oophorectomy or treatment with gonadotropin-releasing hormone agonists.
- Conditions
- HR+/HER2- Breast Cancer
- Being tested
- CDK4/6 inhibitors+Endocrine Therapy
- Keywords
- neoadjuvant, HR+/HER2- breast cancer, CDK4/6 inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDK4/6 inhibitors+Endocrine TherapyDrug
CDK4/6 inhibitors：dalpiciclib,palbociclib,abemaciclib,ribociclib
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | CDK4/6 inhibitors+Endocrine Therapy every 28 days for 6 cycles Receives: Drug: CDK4/6 inhibitors+Endocrine Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as proportion of patients demonstrating either a partial response (PR) or a complete response (CR)
Measured: up to 24 weeks
Secondary outcomes (3)
change in Ki67
change in Ki67 from baseline to end of treatment
Measured: up to 24 weeks
complete cell cycle arrest
The proportion of patients with Ki-67≤2.7% on day 15 of cycle 1 treatment
Measured: up to 4 weeks
Invasive disease free survival（iDFS）
Time from adjuvant therapy to disease recurrence in patients with invasive disease
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start20 Dec 2024
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhong Wu, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xinhong Wu, PhD, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130643
- Sponsor's protocol ID
- OBU-BC-II-209
- Status last verified
- Dec 2024
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm Exploratory Study of Efficacy and Safety of CDK4/6 Inhibitors Combined With Endocrine Therapy in HR+/HER2- Neoadjuvant Therapy for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT07130643
- Acronym / sponsor ID
- OBU-BC-II-209
- Conditions
- HR+/HER2- Breast Cancer
- Keywords
- neoadjuvant, HR+/HER2- breast cancer, CDK4/6 inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xinhong Wu, PhDUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 19 Aug 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 is a single arm, open label, phase 2 trial aimed to investigate the effects and safety of neoadjuvant CDK4/6 inhibitors in combination with endocrine for HR+/HER2- breast cancer. A total of 40 patients with stage II-III HR+/HER2- breast cancer will be enrolled. Six 4-week cycles of adjuvant therapy will be administrated.Premenopausal or perimenopausal patients should combine ovarian function suppression, including bilateral oophorectomy or treatment with gonadotropin-releasing hormone agonists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: CDK4/6 inhibitors+Endocrine TherapyCDK4/6 inhibitors+Endocrine Therapy every 28 days for 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Age ≥18 years old.
- 2. Premenopausal and postmenopausal women or men with stage II-III disease (multifocal and/or multifocal early invasive breast cancer) if all tumors on histopathological examination meet the pathological criteria for ER and/or PR > 10% and HER2- (HER2 expression of 0 or 1+ or 2+ and negative FISH test).
- 3.Patients had to have histologically confirmed ER and (or PR>10%, HER2 -, early-stage invasive disease.
- 4.Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, PD/SD according to tumor evaluation, old age, and basic diseases can not tolerate chemotherapy.
- 5. ECOG PS score 0-2.
Key exclusion criteria (8 listed)
- 1. Prior treatment with any CDK4/6 inhibitor.
- 2. Inflammatory or stage IV or bilateral breast cancer.
- 3. History of allergic reactions caused by chemical or biological components similar to CDK4/6 inhibitors.
- Patients who received any drugs or substances that were effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.
- 5. Uncontrolled coexisting medical conditions may limit adherence to study requirements.
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 |
|---|---|---|
| CDK4/6 inhibitors+Endocrine TherapyCDK4/6 inhibitors：dalpiciclib,palbociclib,abemaciclib,ribociclib | Drug | treatment |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 24 weeks
ORR is defined as proportion of patients demonstrating either a partial response (PR) or a complete response (CR)
3 secondary outcomes
change in Ki67
Time frame: up to 24 weeks
complete cell cycle arrest
Time frame: up to 4 weeks
Invasive disease free survival（iDFS）
Time frame: up to 3 years
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 19 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDK4/6 inhibitors+Endocrine Therapy in people with HR+/HER2- Breast Cancer, run by Xinhong Wu, PhD at 1 site in China.
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 9 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. 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 China. 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 phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 24 weeks). 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 19 Aug 2025.