Breast Cancer Stage IIINCT06810492
The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment
A study testing Ribociclib; abemaciclib; palbociclib; Dalpiciclib in people with Breast Cancer Stage III and Breast Cancer Stage II, run by Hongmei Zheng, PhD.
Trial summary
To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer. This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Stage III, Breast Cancer Stage II
- What is being tested?
- Ribociclib; abemaciclib; palbociclib; Dalpiciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Dec 2027
- Phase
- Interventional
- 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
- Age ≥ 18 years old.
- Premenopausal and postmenopausal stage II-III females or males (patients with multicenter and/or multifocal early-invasive breast cancer) if all histopathological examination of tumors meet the pathological criteria of ER and/or PR>10% and HER2- (HER2 expression 0 or 1+ or 2+ and negative FISH test).
- Patients must have histologically confirmed ER and/or PR >10%, HER2-, early invasive breast cancer.
- Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, tumor evaluation PD/SD, advanced age, and inability to tolerate chemotherapy with underlying diseases.
- ECOG PS score 0-2.
- Patients must be able and willing to swallow and retain oral medications.
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- Premenopausal women within 14 days of enrollment, or women with amenorrhea for less than 12 months at the time of enrollment, must have a negative serum or urine pregnancy test.
- Patients who have received neoadjuvant endocrine therapy are eligible for enrollment as long as they are enrolled within 6 months of initial histologic diagnosis and have completed no more than 2 months of neoadjuvant endocrine therapy.
- Absolute neutrophil count ≥ 1500/µL, platelet ≥ 100000/mm3, hemoglobin ≥ 10g/dL
Who cannot join
- Prior treatment with any CDK inhibitor.
- Inflammatory breast cancer or stage IV breast cancer or bilateral breast cancer.
- History of anaphylaxis caused by chemical or biologic components similar to dalsily.
- Patients who have received any drugs or substances with effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.
- Uncontrolled intercurrent illness that would limit compliance with study requirements.
- Pregnant women or women of childbearing potential with a negative pregnancy test within 14 days prior to admission.
- Patients with any history of malignancy are not eligible.
- Patients who have received endocrine therapy within 5 years prior to the diagnosis of the current malignancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm Exploratory Study of the Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+/HER2- Early Breast Cancer
To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.
- Conditions
- Breast Cancer Stage III, Breast Cancer Stage II
- Being tested
- Ribociclib; abemaciclib; palbociclib; Dalpiciclib
- Keywords
- Hormone receptor (HR) positive, HER2 negative, neoadjuvant treatment, CDK4/6 inhibitors
- 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; abemaciclib; palbociclib; DalpiciclibDrug
Also called Letrozole, Anastrozole, Esomeprazole
Neoadjuvant therapy: CDK4/6 inhibitor combined with endocrine, a total of 6 cycles, 1 cycle every 28 days.
CDK4/6 inhibitors (choose one of the following four types):
- Dalpiciclib 125 mg orally once a day d1-21 every 28 days for a cycle (3 weeks/1 week off)
- Palbociclib 125 mg orally once a day, d1-21, every 28 days in cycles (3 weeks/1 week off)
- Abemaciclib 150 mg orally twice daily in 28-day cycles (may be reduced to 100 mg orally twice daily if not tolerated)
- Ribociclib 400 mg orally once a day in a 28-day cycle Endocrine therapy drugs: take according to the label. Premenopausal patients need to be treated for ovarian function suppression.
| Study group | Role | What they receive |
|---|---|---|
| HR+/HER2- breast cancer patients who are intolerance or insensitivity to neoadjuvant chemotherapy | Experimental | 1. Age ≥ 18 years old.
2. Premenopausal and postmenopausal stage II-III females or males (patients with multicenter and/or multifocal early-invasive breast cancer) if all histopathological examination of tumors meet the pathological criteria of ER and/or PR>10% and HER2- (HER2 expression 0 or 1+ or 2+ and negative FISH test).
3. Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, tumor evaluation PD/SD, advanced age, and inability to tolerate chemotherapy with underlying diseases.
4. ECOG PS score 0-2 Receives: Drug: Ribociclib; abemaciclib; palbociclib; Dalpiciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The main effect evaluation index was Objective response rate (ORR) after CDK4/6 inhibitor combined with endocrine, a total of 6 cycles.
Measured: At the end of Cycle 6 (each cycle is 28 days)
Secondary outcomes (4)
Ki67 variations
Tumor samples were collected by surgical resection during the screening period (mandatory), at the time of treatment for 8 weeks (mandatory), and at the time of surgery (mandatory). Each test center was responsible for collecting samples, and the Hubei cancer Hospital determined the levels of Ki67.
Measured: At the end of Cycle 2(each cycle is 28 days)
complete cell cycle arrest (CCCA; Ki67 ≤ 2.7%)
Ki67 levels were assessed through serial biopsies at baseline , before ET treatment and C2D28 after ET treatment
Measured: 6 months
iDFS
Disease free survival for 3 years and 5 years, which means the rate of patients without local recurrence and distant metastasis in the whole patients at the same group will be calculated with Kaplan Meier survival curves.
Measured: 2 years
QoL
Life quality score was evaluated by European Organization of Research and treatment of Cancer-Questionnaire of Life Quality-C30 Version 3 (EORTC-QLQ-C30 V3), which conduct a series of questions about the patients' physical condition, activity of daily life, adverse reaction and mood condition. The range in the questionnaire for the score is from 1 to 4, in which 1 stands for having no discomfort and 4 stands for having great discomfort.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IIIStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongmei Zheng, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongmei Zheng, PhD, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810492
- Sponsor's protocol ID
- HBCHBCC011
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Baseline data of enrolled patients, endocrine therapeutics, and idfs
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Exploratory Study of the Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+/HER2- Early Breast Cancer
- ClinicalTrials.gov ID
- NCT06810492
- Acronym / sponsor ID
- HBCHBCC011
- Conditions
- Breast Cancer Stage III, Breast Cancer Stage II
- Keywords
- Hormone receptor (HR) positive, HER2 negative, neoadjuvant treatment, CDK4/6 inhibitors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hongmei Zheng, PhDUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 5 Feb 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.
To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HR+/HER2- breast cancer patients who are intolerance or insensitivity to neoadjuvant chemotherapy | Experimental | Drug: Ribociclib; abemaciclib; palbociclib; Dalpiciclib1. Age ≥ 18 years old. 2. Premenopausal and postmenopausal stage II-III females or males (patients with multicenter and/or multifocal early-invasive breast cancer) if all histopathological examination of tumors meet the pathological criteria of ER and/or PR>10% and HER2- (HER2 expression 0 or 1+ or 2+ and negative FISH test). 3. Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, tumor evaluation PD/SD, advanced age, and inability to tolerate chemotherapy with underlying diseases. 4. ECOG PS score 0-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old.
- Premenopausal and postmenopausal stage II-III females or males (patients with multicenter and/or multifocal early-invasive breast cancer) if all histopathological examination of tumors meet the pathological criteria of ER and/or PR>10% and HER2- (HER2 expression 0 or 1+ or 2+ and negative FISH test).
- Patients must have histologically confirmed ER and/or PR >10%, HER2-, early invasive breast cancer.
- Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, tumor evaluation PD/SD, advanced age, and inability to tolerate chemotherapy with underlying diseases.
- ECOG PS score 0-2.
Key exclusion criteria (8 listed)
- Prior treatment with any CDK inhibitor.
- Inflammatory breast cancer or stage IV breast cancer or bilateral breast cancer.
- History of anaphylaxis caused by chemical or biologic components similar to dalsily.
- Patients who have received any drugs or substances with effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.
- Uncontrolled intercurrent illness that would limit compliance with 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 |
|---|---|---|
| Ribociclib; abemaciclib; palbociclib; DalpiciclibAlso: Letrozole, Anastrozole, EsomeprazoleNeoadjuvant therapy: CDK4/6 inhibitor combined with endocrine, a total of 6 cycles, 1 cycle every 28 days. CDK4/6 inhibitors (choose one of the following four types): * Dalpiciclib 125 mg orally once a day d1-21 every 28 days for a cycle (3 weeks/1 week off) * Palbociclib 125 mg orally once a day, d1-21, every 28 days in cycles (3 weeks/1 week off) * Abemaciclib 150 mg orally twice daily in 28-day cycles (may be reduced to 100 mg orally twice daily if not tolerated) * Ribociclib 400 mg orally once a day in a 28-day cycle Endocrine therapy drugs: take according to the label. Premenopausal patients need to be treated for ovarian function suppression. | Drug | HR+/HER2- breast cancer patients who are intolerance or insensitivity to neoadjuvant chemotherapy |
Primary outcome
Objective response rate (ORR)
Time frame: At the end of Cycle 6 (each cycle is 28 days)
The main effect evaluation index was Objective response rate (ORR) after CDK4/6 inhibitor combined with endocrine, a total of 6 cycles.
4 secondary outcomes
Ki67 variations
Time frame: At the end of Cycle 2(each cycle is 28 days)
complete cell cycle arrest (CCCA; Ki67 ≤ 2.7%)
Time frame: 6 months
iDFS
Time frame: 2 years
QoL
Time frame: 1 year
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 17 Mar 2025.
- Individual participant dataSharing planned: Yes. Baseline data of enrolled patients, endocrine therapeutics, and idfs
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ribociclib; abemaciclib; palbociclib; Dalpiciclib in people with Breast Cancer Stage III and Breast Cancer Stage II, run by Hongmei Zheng, PhD.
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: opening soon, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Hongmei Zheng, Doctor (+86 18971624606, zhenghongmeicj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: At the end of Cycle 6 (each cycle is 28 days)). 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 17 Mar 2025.