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Advanced Breast CancerPhase 2NCT05431504

The Efficacy and Safety of Dalpiciclib Plus Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis

A Phase 2 study testing Dalpiciclib in combination with endocrine therapy by Physicians choice in people with Advanced Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a multicenter, single-arm, open-label, Simon's two-stage exploratory clinical trial. 18 eligible patients with advanced breast cancer with visceral crisis will enroll in stage I. If the study enter stage 2 and continue to include 53 assessable subjects (35 in stage 2). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Breast Cancer
What is being tested?
Dalpiciclib in combination with endocrine therapy by Physicians choice
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteChina
Study dates
Jun 2022to Dec 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

  • Postmenopausal or premenopausal/perimenopausal women aged ≥18 meet one of the following:
  • Previous bilateral oophorectomy, or age ≥60 years; or B) age<60. Natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; or C) premenopausal/perimenopausal women must receive LHRH agonists therapy during the study.
  • Female breast cancer patients diagnosed as HR-positive or HER2-negative by pathological examination are not suitable for surgical resection or radiotherapy for the purpose of cure.
  • ER-positive and/or PR-positive are defined as: ≥ 1% of all tumor cells are positively stained (confirmed by investigator review at the site); B) HER2-negative are defined as: 0/1 + by standard immunohistochemistry (IHC); HER2/CEP17 ratio less than 2.0 by ISH or HER2 gene copy number less than 4 (confirmed by investigator review at the site).
  • Any clinical signs or symptoms of symptomatic brain metastasis or visceral metastasis (at least one of the following: carcinomatous meningitis or leptomeningeal metastasis; pleural effusion; ascites; abdominal pain caused by liver or peritoneal metastasis; dyspnea caused by pleural effusion or pulmonary lymphangitis; elevated liver enzymes (> 2 × ULN); rapid elevation of bilirubin > 1.5 × ULN in the absence of Gilbert's syndrome or biliary obstruction; pathologically confirmed bone marrow metastasis; hemoglobin less than 10 g) and patients who cannot tolerate chemotherapy or are considered by the investigator to be inappropriate for chemotherapy or chemotherapy.
  • Adequate bone marrow function. Definitions are as follows: a) neutrophil count (ANC) ≥ 1,500/mm3 (1.5 x 109L) (14 without growth factors); b) platelet count (PLT) ≥ 100,000/mm3 (100 x 109L) (7 without correction); c) hemoglobin (Hb) ≥ 8 g/dL (80 g/L) (7 without correction).
  • Female subjects who are not postmenopausal or surgically sterile must have a serum pregnancy test within 7 days before the first dose and have a negative result, and are willing to abstain from sexual intercourse or use a medically recognized highly effective contraceptive measure after signing the informed consent, during the study, and for 1 year after administration of the study drug.
  • Voluntarily participate in this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.

Who cannot join

  • Patients contraindicated with dalpiciclib.
  • Patients with primary resistance to endocrine therapy. Relapse within 2 years of adjuvant endocrine therapy, or disease progression within 6 months of advanced first-line endocrine therapy.
  • Patients with more than 3 lines of prior endocrine therapy.
  • Patients previously treated with any CDK4/6 inhibitor.
  • Patients with simple bone metastasis.
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 1000 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection of the analytical method) or combined hepatitis B and C co-infection.
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  • Within 6 months before enrollment, the following conditions occur: myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac insufficiency, ≥ grade 2 persistent arrhythmia (according to NCI CTCAE v5.0), atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack) or symptomatic pulmonary embolism.
  • Severe infection occurring within 4 weeks (such as intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical practice) before the first dose, or unexplained fever > 38.5℃ during screening/before the first dose.
  • Inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption.
  • Known hypersensitivity to dalpiciclib and any of its excipients.
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Known history of psychiatric drug abuse or drug use;
  • Female patients who are pregnant or lactating.
  • Any other condition that the investigator considers the subject unsuitable for this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fei Ma contact

86-10-87788060

drmafei@126.com

China1 site

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: An Exploratory Trial of Dalpiciclib in Combination With Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis

This is a multicenter, single-arm, open-label, Simon's two-stage exploratory clinical trial. 18 eligible patients with advanced breast cancer with visceral crisis will enroll in stage I. If the study enter stage 2 and continue to include 53 assessable subjects (35 in stage 2). All eligible patients will receive Dalpiciclib plus endocrine therapy chosen by the Physicians until disease progression, death or intolerable toxicity. Tumor assessment was conducted according to RECIST 1.1 criteria.

Being tested
Dalpiciclib in combination with endocrine therapy by Physicians choice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dalpiciclib in combination with endocrine therapy by Physicians choiceDrug

    Dalpiciclib 150 mg orally once daily for 3 weeks, followed by 1 week off in each 4-week cycle.

    Endocrine therapy including but not limited to fulvestran, tanastrozole, letrozole or exemestane In regular doses

Study groups in NCT05431504
Study groupRoleWhat they receive
Treatment groupExperimentalDalpiciclib in combination with endocrine therapy by physicians choice
Receives: Drug: Dalpiciclib in combination with endocrine therapy by Physicians choice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-month-OS rate

    6-month-Overall Survival rate. Overall Survival , defined as the time from the start of treatment to the date of death, regardless of the cause of death.

    Measured: From the start of treatment to 6 month

Secondary outcomes (9)

  1. Overall Survival (OS)

    Overall Survival , defined as the time from the start of treatment to the date of death, regardless of the cause of death.

    The OS will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.

    Measured: From the start of treatment to 36 month

  2. 1-year-OS rate

    1-year-Overall Survival rate. Overall Survival , defined as the time from the start of treatment to the date of death, regardless of the cause of death.

    Measured: From the start of treatment to 12 month

  3. Progression-Free Survival (PFS)

    Progression-Free Survival is defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.

    The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.

    Measured: From the start of treatment to 36 month

  4. Time to treatment failure (TTF)

    TTF is defined as date of treatment start until permanent treatment discontinuation due to progressive disease or unacceptable toxicity.

    The TTF will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median TTF, hazard ratio with appropriate confidence intervals will be reported.

    Measured: From the start of treatment to 36 month

  5. Objective Overall Response Rate (ORR)

    ORR is defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death.

    The ORR will be reported by percentage with each arms and appropriate confidence intervals.

    Measured: From the start of treatment to 36 month

  6. Clinical Benefit Response (CBR)

    CBR is percentage of participants with best (confirmed) PR or CR or SD for at least 6 months. PR or CR or SD is according to RECIST version 1.1.

    The CBR will be reported by percentage with each arms and appropriate confidence intervals.

    Measured: From the start of treatment to 36 month

  7. Duration of Response (DoR)

    DoR is defined as date of initial confirmed PR/CR until date of progressive disease or death from any cause. PR or CR or SD is according to RECIST version 1.1.

    The DoR will be estimated using Kaplan-Meier method. Kaplan-Meier curves, median DoR, hazard ratio with appropriate confidence intervals will be reported.

    Measured: From the start of treatment to 36 month

  8. Time to response（TTR）

    TTR, defined as the time from the date of randomization to the date of first CR or PR. CR or PR is according to RECIST version 1.1.

    The TTR will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median TTR, hazard ratio with appropriate confidence intervals will be reported.

    Measured: From the start of treatment to 36 month

  9. Adverse events (AEs)

    AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

    The type, grade and frequency of AEs will be reported.

    Measured: From the start of treatment to 36 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study startJun 2022 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431504
Sponsor's protocol ID
MA-BC-II-033
Status last verified
Apr 2022
First submitted
19 Jun 2022
Last updated
24 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mo H, Teng Y, Cai L, Li H, Wu X, Yao J, Wang Y, Lv D, Peng X, Wang S, Chen R, Yi X, Shang Q, He Y, Liu J, Pang Z, Feng T, Ma F. Dalpiciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer and visceral crisis: a multicenter, nonrandomized, phase 2 DARVIN trial. Nat Cancer. 2026 Aug;7(8):1312-1321. doi: 10.1038/s43018-026-01208-0. Epub 2026 Jul 21.

    PubMed 42481711

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dalpiciclib in combination with endocrine therapy by Physicians choice in people with Advanced Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 inclusion and 14 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 24 Jun 2022. 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?

Contact Fei Ma (86-10-87788060, drmafei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month-OS rate (time frame: From the start of treatment to 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05431504, which also lists 1 linked publication.

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 24 Jun 2022.

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