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AzTrials

Breast CancerPhase 2NCT07527806

Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging

A Phase 2 study testing Trastuzumab (Herceptin), Pertuzumab and Combination product: Trastuzumab + Pertuzumab in people with Breast Cancer, run by Peking University Cancer Hospital & Institute.

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
Search all trials

Trial summary

This study evaluates HER2-PET/CT-guided dynamic optimization of neoadjuvant therapy in patients with early-stage HER2-positive breast cancer. Based on metabolic response after two cycles, patients receive either intenstified treatment (Arm A) or de-escalation treatment (Arm B), alongside with a concurrent… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab (Herceptin), Pertuzumab and Combination product: Trastuzumab + Pertuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
No sites listed yet
Study dates
1 May 2026to 31 Dec 2029
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

  • Voluntary participation with written informed consent obtained prior to any study-related procedures
  • Age ≥ 18 years, male or female.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Histologically confirmed HER2-positive (IHC 3+, or IHC 2+ with ISH amplification) stage I-III (cT1-3/cN0-2) breast cancer
  • Tumor diameter ≥ 1.5 cm assessed by imaging, with at least one PET-evaluable lesion present
  • Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status. For Arm B, ER expression ≥ 10% and must be strongly positive.
  • Adequate bone marrow, liver, and renal function: WBC > 3.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, Hb ≥ 10.0 g/dL; total bilirubin ≤ ULN (excluding Gilbert's syndrome), ALP ≤ 2.5 × ULN, AST/ALT ≤ 1.5 × ULN; creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min.
  • Patients who participate in the trial have good compliance and are willing to comply with the follow-up visit.

Who cannot join

  • Prior treatment with any chemotherapy, anti-HER2 therapy, radiotherapy, or endocrine therapy, etc
  • Locally advanced (cT4/cN3) or bilateral breast cancer
  • Patients with known allergies to any active ingredients or excipients of investigational medicinal product
  • Other malignancy diagnosed within 5 years prior to enrollment, excluding cervical carcinoma in situ and cured melanoma skin cancer
  • Left ventricular ejection fraction (LVEF) < 55%
  • Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg)
Show all 15Show fewer
  • Severely cardiovascular disease
  • Current known infection with HIV, hepatitis B virus, or hepatitis C virus
  • Patients with pulmonary disease requiring continuous oxygen therapy, previous history of bleeding diathesis or patient is currently receiving anti-coagulant therapy, or immunosuppressive agent
  • Major surgical procedure or significant traumatic injury
  • Patient has other concurrent severe and/or uncontrolled medical conditions.
  • Concurrent participation in other interventional clinical trial
  • History of receiving any investigational treatment within 28 days prior to randomization
  • Pregnant or breast-feeding women or patients not willing to apply highly effective contraception as defined in the protocol
  • Inability to lie flat or presence of psychiatric disorders such as claustrophobia

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xu Liang contact

010-8819 6406

liangxu15@outlook.com

About this study

Official title: A Prospective, Double-Arm Study on the Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging

This study evaluates HER2-PET/CT-guided dynamic optimization of neoadjuvant therapy in patients with early-stage HER2-positive breast cancer. Based on metabolic response after two cycles, patients receive either intenstified treatment (Arm A) or de-escalation treatment (Arm B), alongside with a concurrent standard-treatment control group (Arm C). The study aims to establish a response-adaptive, imaging-guided treatment paradigm to optimize neoadjuvant therapy in HER2-positive breast cancer.

Read the detailed description

This is a prospective, two-arm, interventional study. Eligible patients with early-stage HER2-positive breast cancer are enrolled into Arm A (TCbHP: trastuzumab, pertuzumab, docetaxel/nab-paclitaxel, and carboplatin) or Arm B (trastuzumab, pertuzumab, CDK4/6 inhibitor, and aromatase inhibitor), based on molecular subtype and patient preference. Patients in the control group (ArmC) will receive standard TCbHP therapy without intervention. All patients will undergo HER2-PET/CT imaging at baseline and after two cycles of treatment. Metabolic response, defined as a ≥40% reduction in SUVmax of target lesions, guides subsequent therapy: responders continue the initial regimen, while non-responders switch to an alternative strategy (ADC in Arm A or TCbHP in Arm B). The primary endpoint is the total pathological complete response (tpCR) rate in Arm A and ArmB.

Conditions
Breast Cancer
Being tested
Trastuzumab (Herceptin), Pertuzumab, Combination product: Trastuzumab + Pertuzumab, Docetaxel or Nab-paclitaxel, carboplatin
Keywords
breast cancer
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 (Herceptin)Drug

    8 mg/kg first dose, followed 6 mg/kg given into the vein (IV; intravenously) every 21 days

  • PertuzumabDrug

    840 mg first dose, followed 420 mg given by IV every 21 days

  • Combination product: Trastuzumab + PertuzumabDrug

    600 mg Pertuzumab, 600 mg Trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days

  • Docetaxel or Nab-paclitaxelDrug

    Docetaxe 75mg/m²/ Nab-paclitaxel：260mg/m²

  • carboplatinDrug

    AUC6

  • CDK4/6 inhibitorDrug

    Ribociclib 600mg once daily every 21days/ Dalpiciclib 150mg once daily every 21days/ Palbociclib 125mg once daily every 21days

  • Aromatase Inhibitor (AI)Drug

    Letrozole 2.5mg once daily/ Anastrozole 1mg once daily/ Exemestane25mg once daily

  • ADCDrug

    T-Dxd: 5.4mg/kg given into the vein (IV; intravenously) every 21 days SHR-A1811: 4.8mg/kg given into the vein (IV; intravenously) every 21 days

Study groups in NCT07527806
Study groupRoleWhat they receive
Cohort AExperimentalThe initial treatment regimen is the TCbHP (Trastuzumab + Pertuzumab + Docetaxel/Nab-paclitaxel + Carboplatin). After two cycles, patients assessed as metabolic responders by HER2 PET continue the TCbHP regimen for a total of six cycles, followed by surgery. Metabolic non-responders are switched to either SHR-A1811 (4.8 mg intravenously every 21 days) or Trastuzumab Deruxtecan (T-DXd, 5.4 mg/kg intravenously every 21 days) for four cycles of intensified therapy.
Receives: Drug: Trastuzumab (Herceptin); Drug: Pertuzumab; Drug: Combination product: Trastuzumab + Pertuzumab; Drug: Docetaxel or Nab-paclitaxel; Drug: carboplatin; Drug: ADC
Cohort BExperimentalThe initial treatment regimen consists of trastuzumab + pertuzumab + CDK4/6 inhibitor + aromatase inhibitor (AI) ± GnRHa. After two cycles, patients assessed as metabolic responders by HER2 PET continue the original regimen for a total of six cycles of dual HER2-antibody (HP), followed by surgery. Non-responders are switched to the TCbHP regimen for another six cycles, followed by surgery.
Receives: Drug: Trastuzumab (Herceptin); Drug: Pertuzumab; Drug: Combination product: Trastuzumab + Pertuzumab; Drug: Docetaxel or Nab-paclitaxel; Drug: carboplatin; Drug: CDK4/6 inhibitor; Drug: Aromatase Inhibitor (AI)
Cohort CActive comparatorPatients who will receive surgery after completion of standard TCbHP regimen were be consecutively enrolled. Neither HER2-PET evaluation nor regimen adjustment based on the evaluation results was allowed.
Receives: Drug: Trastuzumab (Herceptin); Drug: Pertuzumab; Drug: Combination product: Trastuzumab + Pertuzumab; Drug: Docetaxel or Nab-paclitaxel; Drug: carboplatin

What is being measured

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

  1. rate of pathologic complete response (pCR)

    Proportion of participants who have no evidence by H\&E staining of residual invasive disease

    Measured: Up to 6 months after treatment start

Secondary outcomes (1)

  1. SUVmax change on HER2-PET

    The change in SUVmax value of HER2-PET after 2 cycles of treatment compared to the baseline level

    Measured: Up to 6 months after treatment start

Timeline

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

  1. First posted14 Apr 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 May 2029 (estimated)
  4. Study completion31 Dec 2029 (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
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07527806
Sponsor's protocol ID
L259061
Status last verified
Apr 2026
First submitted
7 Apr 2026
Last updated
17 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab (Herceptin), Pertuzumab and Combination product: Trastuzumab + Pertuzumab in people with Breast Cancer, run by Peking University Cancer Hospital & Institute.

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 15 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 Apr 2026. 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 Xu Liang (010-8819 6406, liangxu15@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of pathologic complete response (pCR) (time frame: Up to 6 months after treatment start). 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 NCT07527806.

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 Apr 2026.

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