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AzTrials

Advanced Breast CancerPhase 2NCT06176534

Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial

A Phase 2 study testing Experimental: chemotheyapy and Active Comparator: endocrine therapy in people with Advanced Breast Cancer and Treatment, run by Henan Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To observe the differences in the efficacy of Combination followed by maintenance chemotherapy versus CDK4/6 inhibitor combined with endocrine therapy in HR low expression /HER2 negative advanced breast cancer, and to provide new evidence for the best treatment of HR low expression /HER2 negative advanced breast… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Experimental: chemotheyapy and Active Comparator: endocrine therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteChina
Study dates
1 Jan 2024to 20 Dec 2026
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age ≥18 years old; Invasive breast cancer with metastatic disease confirmed by histological or cytological examination; Patients without pathologically or cytologically confirmed metastatic disease should have clear evidence of metastasis by physical examination or radiological studies;
  • The most recent pathological report of biopsy confirmed HR low expression and HER2 negative.
  • HR low expression was defined as 1-50% ER expression by immunohistochemistry (IHC); Or ER<1% and PR≥1%; Patients with ER expression of 1-10% or ER-/ PR-positive patients were eligible for inclusion after careful evaluation by the investigator, and those with a small tumor burden and candidates for endocrine therapy were eligible.
  • HER2-negative definition: IHC 0 or 1+; If the IHC was 2+, it was confirmed negative by fluorescence in situ hybridization (FISH).
  • at least one measurable lesion;
  • No previous salvage chemotherapy for metastatic disease was required, and first-line endocrine therapy was allowed;
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  • no previous CDK4/6 inhibitor; For adjuvant CDK4/6i treatment, recurrence and metastasis were required more than 1 year after drug withdrawal.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, life expectancy is more than 12 weeks;
  • Adequate function of major organs.
  • All adverse events recovered to grade 1 or less before enrollment (NCI CTCAE version 5.0);
  • patients without major organ dysfunction and heart disease;
  • Women and men of childbearing potential must agree to use appropriate contraception before and during study participation.

Who cannot join

  • symptomatic, uncontrolled brain or leptomeningeal metastases; Patients who had received previous systemic radical treatment for brain metastases (radiotherapy or surgery), if stable disease had been maintained for at least 1 month as confirmed by imaging, and if systemic hormone therapy (dose 10mg/ day prednisone or other effective hormones) for more than 2 weeks without clinical symptoms.
  • patients received radiotherapy, chemotherapy, major surgery, targeted therapy or immunotherapy within 2 weeks before enrollment; Patients received endocrine therapy within 1 week before enrollment. Chemotherapy with nitrosourea or mitomycin was administered within 6 weeks before enrollment.
  • participated in other clinical trials of new drugs within 4 weeks before enrollment;
  • there can not be controlled by drainage or pneumatic methods third space effusion;
  • patients with other malignant tumors within the past 3 years, excluding radical cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;
  • suffering from serious or uncontrolled diseases, including but not limited to: 1) active viral infection, such as HIV or HBV active (HbsAg positive and HBV-DNA≥103, hepatitis C antibody positive); 2) history of severe cardiovascular disease: uncontrolled hypertension; Myocardial infarction, unstable arrhythmia, congestive heart failure, pericarditis, myocarditis, etc. Patients with NYHA class ⅲ-ⅳ cardiac dysfunction, or left ventricular ejection fraction (LVEF) 50% by echocardiography; 3) severe infection (e.g., intravenous antibiotic, antifungal, or antiviral therapy according to clinical practice) within 4 weeks prior to the first dose or unexplained fever during screening/before the first dose; 38.3°C (fever due to cancer, as judged by the investigator, was eligible);
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  • patients with a history of psychotropic drug abuse and unable to abstain or with mental disorders; Or accompanied by swallowing and absorption dysfunction;
  • patients with other concomitant diseases that seriously endanger the safety of patients or affect the completion of the study according to the judgment of the investigators;
  • patients with known history of allergy to the components of this regimen; A history of immunodeficiency, including testing positive for HIV, HCV or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation;
  • pregnant or lactating women;
  • Patients deemed unsuitable for inclusion by the investigators.

Trial locations and contacts

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

Min Yan, M.D. contact

+8615713857388

ym200678@126.com

China1 site, 1 recruiting

  • Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University

    Zhengzhou, Henan

    Min Yan, Doctor, +86 15713857388, ym200678@126.com

    Min Yan, Doctor

    Recruiting

Other trials in China

About this study

To observe the differences in the efficacy of Combination followed by maintenance chemotherapy versus CDK4/6 inhibitor combined with endocrine therapy in HR low expression /HER2 negative advanced breast cancer, and to provide new evidence for the best treatment of HR low expression /HER2 negative advanced breast cancer, and to explore the efficacy and safety of combined/maintenance chemotherapy.

Read the detailed description

To observe the differences in the efficacy of Combination followed by maintenance chemotherapy versus CDK4/6 inhibitor combined with endocrine therapy in HR low expression /HER2 negative advanced breast cancer, and to provide new evidence for the best treatment of HR low expression /HER2 negative advanced breast cancer, and to explore the efficacy and safety of combined/maintenance chemotherapy.

Being tested
Experimental: chemotheyapy, Active Comparator: endocrine therapy

What participants receive

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

  • Experimental: chemotheyapyDrug

    Also called Vinorelbine 25mg/m2，day 1 and day 8 + Capecitabine 2000mg/m2，from day1 to DAY 14

    nab-paclitaxel 130mg/m2，day 1 and day 8 + Capecitabine 2000mg/m2, followed by nab-paclitaxel 130mg/m2，day 1 and day 8 or Capecitabine from day1 to DAY 14 Vinorelbine 25mg/m2，day 1 and day 8 + Capecitabine 2000mg/m2，from day1 to DAY 14

  • Active Comparator: endocrine therapyDrug

    palbociclib 125mg per day for 21days Dalpiciclib 150mg per day for 21days Letrozole 2.5mg per day Anastrozole 1mg per day fulvestrant 500mg per 28 days

Study groups in NCT06176534
Study groupRoleWhat they receive
AExperimentalnab-paclitaxel 130mg/m2，day 1 and day 8 Capecitabine 2000mg/m2，from day1 to DAY 14 Vinorelbine 25mg/m2，day 1 and day 8
Receives: Drug: Experimental: chemotheyapy
BActive comparatorpalbociclib/Dalpiciclib Letrozole/Anastrozole/fulvestrant
Receives: Drug: Active Comparator: endocrine therapy

What is being measured

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

  1. ORR by investigator using RECIST Guideline (Version 1.1)

    ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR assessed by the investigator according to RECIST version 1.1

    Measured: 6 weeks

Secondary outcomes (3)

  1. PFS

    PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first

    Measured: up to 1.5 years

  2. Adverse events

    Proportion of participants experienced adverse events during the study period

    Measured: up to 1.5 years

  3. OS

    OS was defined as the time from first dose to death for any cause

    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.

  1. First posted19 Dec 2023
  2. Study start1 Jan 2024
  3. Primary completion20 Dec 2025 (estimated)
  4. Study completion20 Dec 2026 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06176534
Sponsor's protocol ID
HNCH-MBC013
Status last verified
Aug 2024
First submitted
9 Dec 2023
Last updated
20 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Experimental: chemotheyapy and Active Comparator: endocrine therapy in people with Advanced Breast Cancer and Treatment, run by Henan Cancer Hospital 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 12 inclusion and 11 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 20 Aug 2024. 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 Min Yan, M.D. (+8615713857388, ym200678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR by investigator using RECIST Guideline (Version 1.1) (time frame: 6 weeks). 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 NCT06176534.

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 20 Aug 2024.

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