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

NCT04281641 | Recruiting

• 1 other identifier: SCHBCC-NO28
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percent Change in Standardized Uptake Value (SUV) on Positron Emission Tomography and Change in Gene Expression With Response

  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.

  From baseline to day 15

Secondary Outcomes (4)

• Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)

  Immediately after the surgery

• Invasive disease-free survival (iDFS) (excluding Second Primary Non-Breast Cancer [SPNBC])

  Following surgery until Year 5

• iDFS (including SPNBC)

  Following surgery until Year 5

• Overall survival (OS)

  Following surgery until Year 5

Study Arms (1)

TCHP

EXPERIMENTAL

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.

Diagnostic Test: TCHP

Interventions

TCHP DIAGNOSTIC_TEST

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.

TCHP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer Center, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Central Study Contacts

Jiong Wu, MD

CONTACT

+862164175590; wujiong1122@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Breast Surgery Vice President, Cancer Hospital, Fudan University

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 24, 2020
• Study Start: April 21, 2020
• Primary Completion: April 30, 2025
• Study Completion (Estimated): April 30, 2030
• Last Updated: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)