Recruiting
Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer
This study is to explore the markers in early prediction of the efficacy of pre-operative pertuzumab plus trastuzumab (PH) combined with chemotherapy for early stage or locally advanced human epidermal growth factor receptor-2 (HER-2) positive primary breast cancer.
ClinicalTrials.gov IDNCT04281641
PhaseNA
Enrollment94
SponsorFudan University
Age18 Years
SexALL
Conditions studied
HER2-positive Breast Cancer
About this study
This study is to explore the markers in early prediction of the efficacy of pre-operative pertuzumab plus trastuzumab (PH) combined with chemotherapy for early stage or locally advanced human epidermal growth factor receptor-2 (HER-2) positive primary breast cancer.
Interventions
- Diagnostic Test: TCHP — Drug: Trastuzumab 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV Other Name: Herceptin Drug: Pertuzumab 840 mg as a loading dose, then 420 mg every 3 weeks, IV Other Name: Perjeta Drug: carboplatin at target area under the plasma concentration-time curve (AUC) 6 Drug: docetaxel at a starting dose of 75 mg/m2 then to 60mg/m2 (q3w). All study drugs were administered intravenously. Procedure: 18-FDG-PET and 68 Ga-Affibody HER-2 Imaging PET will be performed at baseline, on day 15 and before surgery Genomic alterations (mutations/somatic rearrangements) are detected at baseline, on day 15 and before surgery.
Primary outcomes
- Percent Change in Standardized Uptake Value (SUV) on Positron Emission Tomography and Change in Gene Expression With Response (From baseline to day 15)
Eligibility information
Inclusion Criteria:
1. Female or male, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy.
2. Primary tumor greater than (\>) 2 cm in diameter.
3. Age ≥ 18 years and \< 70 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1.
5. Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 55%
6. Availability of tumor tissue specimen after surgery.
7. Participants agree to undergo a core needle biopsy for genomic testing and organoid drug sensitivity assay.
8. Histologically proven diagnosis of breast cancer.
9. Patients have HER2-positive disease. HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH).
10. Had hormonal receptors (ER and PgR) assessed.
11. Signed informed consent.
12. Able to comply with the protocol.
Exclusion Criteria:
1. Metastatic disease (Stage IV) or bilateral breast cancer.
2. Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer.
3. Prior breast or non-breast malignancy within 5 years prior to study entry.
4. Inadequate bone marrow, renal, or liver function
5. History or evidence of cardiovascular condition
6. Severe, uncontrolled systemic disease
7. Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications.
8. Pregnancy or breast-feeding women.
9. Participants who received any investigational treatment within 4 weeks of study start.
10. Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
11. Current chronic daily treatment with corticosteroids (dose \>10 mg methylprednisolone or equivalent \[excluding inhaled steroids\]).
12. Known hypersensitivity to any of the study drugs or excipients
Study locations
- Shanghai Cancer Center, Fudan University, Shanghai, Shanghai Municipality 200000 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.