Clinical trial · Interventional
Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer
Gene Expression Assays and 68 Ga-Affibody HER-2 Imaging PET in Predicting Response to Treatment With Trastuzumab and Pertuzumab Before Surgery in Chinese Patients With HER2 Positive Breast Cancer
NCT04281641CI-TRIAL-00044950PHC-BCrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TCHP | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TCHP
- description
- Neoadjuvant Therapy (Cycles 1-7): Cycle 1: Pertuzumab (840mg loading dose, 420mg maintenance dose) + Trastuzumab (8mg/kg loading dose, 6-mg/kg maintenance dose) Cycle 2-7: Pertuzumab (840mg loading dose, 420mg maintenance dose) + Trastuzumab (8mg/kg loading dose, 6-mg/kg maintenance dose) + followed by carboplatin at target area under the plasma concentration-time curve (AUC) 6 and docetaxel at a starting dose of 75 mg/m2 then to 60mg/m2 (q3w). Adjuvant Therapy:patients would complete 1 year of PH-based regimen in the adjuvant setting. Patients are assessed by \[18F\]Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and 68Ga-Affibody HER-2 Imaging PET. Besides, the changes of biomarkers would be examined by gene sequencing and organoid drug sensitivity test.
- interventionNames
- Diagnostic Test: TCHP
Primary outcomes (1)
- measure
- Percent Change in Standardized Uptake Value (SUV) on Positron Emission Tomography and Change in Gene Expression With Response
- timeFrame
- From baseline to day 15
- description
- Change in SUVmax from baseline to Day 15 on 18-FDG PET and 68Ga-Affibody HER-2 Imaging PET in correlation with pathological complete response (pCR) in patients treated with preoperative pertuzumab/trastuzumab.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDYang B, Chen M, Li P, Xiao X, Xiu B, Bai J, Sun Y, Xu X, Zhang J, Qiao Y, Xue J, Shao Z, Song S, Wu J. A prospective single-center cohort study: integrating PET imaging and genomics to identify early biomarkers of response to dual-targeted PH neoadjuvant therapy in breast cancer. Int J Surg. 2026 Feb 1;112(2):3312-3324. doi: 10.1097/JS9.0000000000003931. Epub 2025 Nov 11. PMID 41231642