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

STATUS

Recruiting
End date

Apr 30, 2030
participants needed

94
sponsor

Fudan University

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Updated on 19 February 2024

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cancer

breast cancer

epidermal growth factor receptor

growth factor

ejection fraction

immunohistochemistry

trastuzumab

core needle biopsy

primary tumor

pertuzumab

epidermal growth factor

adjuvant therapy

erbb2

her-2

her2 gene amplification

her1

HER2

her2+ breast cancer

pertuzumab + trastuzumab

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
Age	18years - 70years
Treatment	TCHP
Clinical Study Identifier	NCT04281641
Sponsor	Fudan University
Last Modified on	19 February 2024

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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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pertuzumab + trastuzumab

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