Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer (PHC-BC)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2030
  • participants needed
    94
  • sponsor
    Fudan University
Updated on 5 March 2022
cancer
ejection fraction
breast cancer
growth factor
pertuzumab
immunohistochemistry
HER2
primary tumor
trastuzumab
her-2
epidermal growth factor
core needle biopsy
her1

Summary

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.

Description

This study is to evaluate the correlation between early changes in multiple markers and pathological complete response in breast and lyphm nodes (tpCR) in patients with HER2-positive breast cancer receiving carboplatin, docetaxel and trastuzumab plus pertuzumab (TCHP) pre-operatively. The markers would be examined by gene expression assays, fluorodeoxyglucose positron emission tomography (18F-FDG-PET), 68 Ga-Affibody HER-2 Imaging PET, and organoid drug sensitivity test. Approximately 94 patients were treated with PH-based neoadjuvant therapy followed by surgery, and would complete 1 year of PH-based regimen in the adjuvant setting. The primary endpoint is the percent change of SUVmax from baseline to Day 15 (after the first cycle of anti HER-2 targeting drug treatment) on FDG PET and HER-2 imagining PET in correlation with pathological complete response (pCR) in patients treated with preoperative pertuzumab and trastuzumab. pCR was defined as no viable invasive cancer in breast and axilla by local pathology review.

Details
Condition HER2-positive Breast Cancer
Treatment TCHP
Clinical Study IdentifierNCT04281641
SponsorFudan University
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female or male, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy
Primary tumor greater than (>) 2 cm in diameter
Age 18 years and < 70 years
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1
Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55%
Availability of tumor tissue specimen after surgery
Participants agree to undergo a core needle biopsy for genomic testing and organoid drug sensitivity assay
Histologically proven diagnosis of breast cancer
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)
Had hormonal receptors (ER and PgR) assessed
Signed informed consent
Able to comply with the protocol

Exclusion Criteria

Metastatic disease (Stage IV) or bilateral breast cancer
Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer
Prior breast or non-breast malignancy within 5 years prior to study entry
Inadequate bone marrow, renal, or liver function
History or evidence of cardiovascular condition
Severe, uncontrolled systemic disease
Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications
Pregnancy or breast-feeding women
Participants who received any investigational treatment within 4 weeks of study start
Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone or equivalent [excluding inhaled steroids])
Known hypersensitivity to any of the study drugs or excipients
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