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AzTrials

Advanced Breast CancerPhase 2NCT07037199

Efficacy and Safety of Trastuzumab Rezetecan Followed by CDK4/6 Inhibitors and Endocrine Therapy in HR+/HER2-Low/Ultra-Low Advanced Breast Cancer

A Phase 2 study testing Trastuzumab rezetecan + CDK4/6 inhibitors + endocrine therapy in people with Advanced Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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

This multicenter, prospective phase II clinical trial evaluates the efficacy and safety of sequential Trastuzumab rezetecan followed by dalpiciclib plus endocrine therapy (fulvestrant or aromatase inhibitors) in 45 patients with HR+/HER2-low/ultra-low advanced breast cancer. 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?
Trastuzumab rezetecan + CDK4/6 inhibitors + endocrine therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
18 Aug 2025to 30 Jun 2030
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

  • Participants must meet all of the following criteria:
  • 1. Female patients aged ≥18 years. 2. Pathologically confirmed HER2-low/ultra-low, HR-positive unresectable or metastatic breast cancer:
  • HER2-low: IHC 1+ or IHC 2+/ISH-negative；HER2-ultra-low: IHC 0 with membranous staining (>0 but <1+). HR+: ≥10% tumor cells with ER/PR nuclear staining (verified by central pathology review).
  • Disease stage: Recurrent/metastatic disease; locally recurrent cases must be deemed unresectable by investigators.
  • 3. Prior therapy:
  • Disease progression after endocrine therapy (ET) + CDK4/6 inhibitor in the advanced/metastatic setting.
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  • Progression within 12 months of adjuvant ET + CDK4/6 inhibitor allowed.
  • ≤1 line of prior ET and ≤1 line of chemotherapy for advanced disease. 4. Measurable disease per RECIST 1.1 (including lytic/mixed bone-only metastases).
  • 5. ECOG PS 0-1. 6. Adequate organ function (no transfusions/G-CSF within 2 weeks prior):
  • Hematologic: ANC >1.5×10⁹/L; platelets >90×10⁹/L; Hb >90 g/L.
  • Hepatic: Total bilirubin ≤ULN (≤2×ULN if Gilbert's syndrome). ALT/AST ≤1.5×ULN (≤5×ULN with liver metastases). Alkaline phosphatase ≤2.5×ULN.
  • Renal: BUN/Cr ≤1.5×ULN.
  • Cardiac: LVEF ≥50%;
  • QTcF <470 ms. 7. Voluntary participation with signed informed consent.

Who cannot join

  • Participants will be excluded if they meet any of the following conditions:
  • Prior anti-HER2 therapy at any stage (including HER2-ADCs such as T-DM1 or T-DXd).
  • Significant cardiac disease, including:
  • 1) Heart failure or systolic dysfunction (LVEF <50%). 2) High-risk/treated angina or arrhythmias (e.g., Type II Mobitz II/third-degree AV block, ventricular tachycardia).
  • 3) Clinically significant valvular disease. 4) ECG-confirmed transmural myocardial infarction. 5) Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg). 3. Interstitial lung disease (ILD)/pneumonitis:
  • History of non-infectious ILD requiring steroids.
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  • Current ILD or suspected ILD that cannot be ruled out by imaging at screening. 4. Impaired drug absorption due to:
  • 1) Dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting oral medication intake.
  • 5. Uncontrolled third-space effusions (e.g., pleural/peritoneal effusions) not manageable by drainage.
  • 6. Pregnancy, lactation, or unwillingness to use effective contraception during and for 7 months post-treatment.
  • 7. Other exclusions:
  • Severe comorbidities interfering with treatment (e.g., active HBV, pulmonary infections requiring therapy).
  • Any condition deemed unsuitable by investigators.

Trial locations and contacts

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

JianLi Zhao, PhD contact

008615920589334

zhaojianli1988@126.com

China1 site, 1 recruiting

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong, 510120

    Jianli Zhao, +8615920589334, zhaojianli1988@126.com

    Recruiting

Other trials in China

About this study

This multicenter, prospective phase II clinical trial evaluates the efficacy and safety of sequential Trastuzumab rezetecan followed by dalpiciclib plus endocrine therapy (fulvestrant or aromatase inhibitors) in 45 patients with HR+/HER2-low/ultra-low advanced breast cancer. Enrolled patients will receive Trastuzumab rezetecan monotherapy for 6-8 cycles until clinical benefit, then transition to CDK4/6 inhibitors with endocrine therapy until disease progression or unacceptable toxicity. The primary endpoint is progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), overall survival (OS), and treatment-related adverse events (TRAEs). The study will be conducted at Sun Yat-sen Memorial Hospital and collaborating centers.

Being tested
Trastuzumab rezetecan + CDK4/6 inhibitors + endocrine therapy
Keywords
endocrine therapy, breast cancer, Trastuzumab rezetecan, 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.

  • Trastuzumab rezetecan + CDK4/6 inhibitors + endocrine therapyDrug

    sequential Trastuzumab rezetecan followed by CDK4/6 inhibitors (Dalpiciclib, Abemaciclib, Ribociclib, Palbociclib) plus endocrine therapy (fulvestrant or aromatase inhibitors)

Study groups in NCT07037199
Study groupRoleWhat they receive
HR+/HER2-low/ultra-low advanced breast cancerExperimentalEnrolled patients will be HR+/HER2-low/ultra-low advanced breast cancer patients and receive SHR-A1811 monotherapy for 6-8 cycles until clinical benefit, then transition to dalpiciclib with endocrine therapy until disease progression or unacceptable toxicity.
Receives: Drug: Trastuzumab rezetecan + CDK4/6 inhibitors + endocrine therapy

What is being measured

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

  1. Progression-free survival (PFS)

    Progression-free survival rate at 2 years, calculated from the date of randomization to the first documented disease progression (per RECIST 1.1) or death due to any cause, whichever occurred first

    Measured: 2-year PFS

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    The proportion of patients achieving ≥30% reduction in tumor volume (sum of complete response [CR] and partial response [PR] rates) during the 2-year follow-up period, assessed from enrollment. The primary endpoint is the percentage of patients with ≥30% tumor shrinkage, as evaluated by investigators per RECIST 1.1 criteria

    Measured: ORR (CR+PR rate per RECIST 1.1) with ≥30% tumor reduction at 2 years post-enrollment, assessed by investigators

  2. Clinical Benefit Rate (CBR)

    The proportion of patients achieving either ≥30% tumor reduction or maintaining stable disease (SD) for ≥24 weeks during the 2-year follow-up period (sum of complete response [CR], partial response [PR], and SD lasting ≥24 weeks), as assessed by investigators according to RECIST 1.1 criteria

    Measured: CBR (CR+PR+SD≥24 weeks rate per RECIST 1.1) at 2 years post-enrollment, assessed by investigators.

  3. Disease Control Rate (DCR)

    The proportion of patients achieving tumor stabilization or reduction (sum of complete response [CR], partial response [PR], and stable disease [SD] rates) during the 2-year follow-up period from enrollment, as assessed by investigators per RECIST 1.1 criteria

    Measured: DCR (CR+PR+SD rate per RECIST 1.1) at 2 years post-enrollment (investigator-assessed)

  4. Overall Survival (OS)

    The time from enrollment to death from any cause during the 2-year follow-up period, with the primary endpoint being the duration from randomization to death event

    Measured: OS (time from enrollment to death) at 2-year follow-up (primary endpoint)

  5. Treatment-Related Adverse Events (TRAEs)

    All adverse events (AEs) occurring from enrollment until treatment discontinuation during the 2-year follow-up period, including their type, incidence rate, severity grade (assessed per NCI-CTCAE v5.0 criteria), seriousness, and relationship to the study treatment.

    Measured: TRAEs (all AEs from first dose to 30 days post-treatment) graded by CTCAE v5.0, with causality assessment

  6. Quality of Life (QoL)

    Assessed using the EORTC QLQ-C30 questionnaire at baseline (enrollment), during each efficacy evaluation timepoint, and at treatment discontinuation throughout the 2-year follow-up period

    Measured: QoL (EORTC QLQ-C30) evaluated serially from baseline to treatment discontinuation over 2 years

Timeline

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

  1. First posted25 Jun 2025
  2. Study start18 Aug 2025
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2030 (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
Model description
HR+/HER2-low/ultra-low advanced breast cancer
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07037199
Sponsor's protocol ID
SDE-BRCA
Status last verified
Dec 2025
First submitted
13 Jun 2025
Last updated
31 Dec 2025
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 Trastuzumab rezetecan + CDK4/6 inhibitors + endocrine therapy in people with Advanced Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 14 inclusion and 13 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 31 Dec 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?

Contact JianLi Zhao, PhD (008615920589334, zhaojianli1988@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 2-year PFS). 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 NCT07037199.

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 31 Dec 2025.

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