Breast CancerPhase 2NCT07047755
Trastuzumab Rezetecan Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
A Phase 2 study testing Trastuzumab Rezetecan and Pertuzumab in people with Breast Cancer, run by Henan Cancer Hospital.
Trial summary
This is a prospective, open-label, phase II study evaluating the efficacy and safety of Trastuzumab Rezetecan in combination with pertuzumab in early or locally advanced HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab Rezetecan and Pertuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 28 Feb 2031
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-70 years;
- Histopathologically confirmed HER2 positive breast cancer;
- Patients were diagnosed with stage II-III breast cancer;
- At least one measurable target lesion according to RECIST V1.1;
- ECOG performance status score of 0 to 1;
- Life expectancy ≥12 weeks;
- Adequate bone marrow reserve and organ system function reserve;
- Participants should be able and willing to comply with the study protocol requirement;
Who cannot join
- Breast cancer not histologically confirmed;
- Known inherited or acquired bleeding and thrombotic tendencies;
- Known allergy or contraindication to the study drug and its excipients;
- Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- Concurrent receipt of any other form of anti-cancer therapy;
- History of a second primary malignancy, except for adequately treated skin cancer;
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- Participation in other drug clinical trials within 4 weeks before enrollment;
- Major surgical procedures unrelated to breast cancer within 4 weeks prior to the first drug administration, or not fully recovered from such procedures;
- Presence of any active autoimmune disease or history of autoimmune disease with potential for recurrence;
- Uncontrolled or significant cardiovascular and cerebrovascular diseases;
- Subjects with known or suspected interstitial pneumonia;
- Presence of active hepatitis B, hepatitis C, liver cirrhosis;
- Pregnant or lactating female patients;
- History of definite neurological or mental disorders, or any other conditions that the investigator believes make the patient unsuitable for participating in this study.
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: Trastuzumab Rezetecan Plus Pertuzumab as Neoadjuvant Treatment for Early or Locally Advanced HER2-positive Breast Cancer：A Prospective, Open-label, Phase II Trial
This is a prospective, open-label, phase II study evaluating the efficacy and safety of Trastuzumab Rezetecan in combination with pertuzumab in early or locally advanced HER2-positive breast cancer.
Read the detailed description
Patients with early-stage or locally advanced HER2-positive breast cancer were planned to be enrolled and subjected to neoadjuvant therapy with the regimen of Trastuzumab Rezetecan combined with Pertuzumab. The primary objective was to evaluate the efficacy and safety of Trastuzumab Rezetecan plus Pertuzumab as neoadjuvant treatment for early-stage or locally advanced HER2-positive breast cancer. Subjects will continue medication until surgery is completed, or until disease progression, intolerable toxicity, withdrawal of informed consent, or when the investigator determines that medication must be terminated.
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab Rezetecan, Pertuzumab
- 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 RezetecanDrug
Trastuzumab Rezetecan
PertuzumabDrug
Pertuzumab
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Trastuzumab Rezetecan; Pertuzumab Receives: Drug: Trastuzumab Rezetecan; Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
Total pathological complete response (tpCR: ypT0-is，ypN0)
Measured: At the time of surgery
Secondary outcomes (4)
iDFS
Invasive disease-free survival
Measured: Up to approximately 5 years
EFS
Event-free survival
Measured: Up to approximately 5 years
ORR
Objective Response Rate
Measured: Up to approximately 24 weeks after the first administration
AEs
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to CTCAE 5.0
Measured: From the first dose until 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion28 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047755
- Sponsor's protocol ID
- HELEN-027
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trastuzumab Rezetecan Plus Pertuzumab as Neoadjuvant Treatment for Early or Locally Advanced HER2-positive Breast Cancer：A Prospective, Open-label, Phase II Trial
- ClinicalTrials.gov ID
- NCT07047755
- Acronym / sponsor ID
- HELEN-027
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 2 Jul 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 prospective, open-label, phase II study evaluating the efficacy and safety of Trastuzumab Rezetecan in combination with pertuzumab in early or locally advanced HER2-positive breast cancer.
Detailed description
Patients with early-stage or locally advanced HER2-positive breast cancer were planned to be enrolled and subjected to neoadjuvant therapy with the regimen of Trastuzumab Rezetecan combined with Pertuzumab. The primary objective was to evaluate the efficacy and safety of Trastuzumab Rezetecan plus Pertuzumab as neoadjuvant treatment for early-stage or locally advanced HER2-positive breast cancer. Subjects will continue medication until surgery is completed, or until disease progression, intolerable toxicity, withdrawal of informed consent, or when the investigator determines that medication must be terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Trastuzumab Rezetecan, Drug: PertuzumabTrastuzumab Rezetecan; Pertuzumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients aged 18-70 years;
- Histopathologically confirmed HER2 positive breast cancer;
- Patients were diagnosed with stage II-III breast cancer;
- At least one measurable target lesion according to RECIST V1.1;
- ECOG performance status score of 0 to 1;
Key exclusion criteria (14 listed)
- Breast cancer not histologically confirmed;
- Known inherited or acquired bleeding and thrombotic tendencies;
- Known allergy or contraindication to the study drug and its excipients;
- Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- Concurrent receipt of any other form of anti-cancer therapy;
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 |
|---|---|---|
| Trastuzumab RezetecanTrastuzumab Rezetecan | Drug | Treatment group |
| PertuzumabPertuzumab | Drug | Treatment group |
Primary outcome
pCR rate
Time frame: At the time of surgery
Total pathological complete response (tpCR: ypT0-is，ypN0)
4 secondary outcomes
iDFS
Time frame: Up to approximately 5 years
EFS
Time frame: Up to approximately 5 years
ORR
Time frame: Up to approximately 24 weeks after the first administration
AEs
Time frame: From the first dose until 30 days after last dose
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 2 Jul 2025.
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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 Phase 2 study testing Trastuzumab Rezetecan and Pertuzumab in people with Breast Cancer, run by Henan Cancer Hospital.
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 2 Jul 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.
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 Zhenzhen Liu (+86-13603862755, liuzhenzhen73@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: At the time of surgery). 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 2 Jul 2025.