Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel.

NCT04629846 | Completed Phase 3

• 1 other identifier: QL1209-301
• Study Type: interventional
• Target: 517
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with trastuzumab + QL1209 + docetaxel compared with trastuzumab + pertuzumab + docetaxel in the participants with early-stage or locally advanced HER2-positive and estrogen receptor/progesterone receptor negative breast cancer. The anticipated treatment duration is approximately 140 days.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Total pathologic complete response (tpCR) rate

  Total pathologic complete response (tpCR) rate, defined as ypT0/is, ypN0 as assessed by an Independent Review Committee (IRC)

  Approximately 26 months after randomization of the first patient, when all patients have completed the treatment completion/discontinuation visit

Secondary Outcomes (4)

• Percentage of Participants With tpCR as Assessed by the Local Pathologist

  At surgery

• Percentage of Participants With Breast Pathologic Complete Response (bpCR) assessed by the IRC

  Approximately 26 months after randomization of the first patient, when all patients have completed the treatment completion/discontinuation visit

• Percentage of Participants With bpCR as Assessed by the Local Pathologist

  At surgery

• Percentage of Participants With an Objective Response

  Before surgery

Study Arms (2)

Trastuzumab Plus（+） QL1209 + Docetaxel

EXPERIMENTAL

Prior to surgery: trastuzumab, QL1209, and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: QL1209 Drug: Trastuzumab Procedure: Surgery

Drug: Trastuzumab; Drug: QL1209; Drug: Docetaxel; Procedure: surgery

Trastuzumab Plus（+） Pertuzumab + Docetaxel

ACTIVE COMPARATOR

Prior to surgery: trastuzumab,pertuzumab , and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: Pertuzumab Drug: Trastuzumab Procedure: Surgery

Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel; Procedure: surgery

Interventions

Trastuzumab DRUG

Trastuzumab IV infusion in 3-week cycles. Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4.

Also known as: Herceptin®

Trastuzumab Plus（+） Pertuzumab + Docetaxel; Trastuzumab Plus（+） QL1209 + Docetaxel

QL1209 DRUG

QL1209 IV infusion in 3-week cycles. Prior to surgery (neoadjuvant treatment): 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4.

Also known as: Recombinant anti-HER-2 domain Ⅱ humanized monoclonal antibody injection

Trastuzumab Plus（+） QL1209 + Docetaxel

Pertuzumab DRUG

Pertuzumab IV infusion in 3-week cycles. Prior to surgery (neoadjuvant treatment): 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4.

Also known as: Perjeta®

Trastuzumab Plus（+） Pertuzumab + Docetaxel

Docetaxel DRUG

Docetaxel IV infusion in 3-week cycles. Neoadjuvant treatment: 75 mg/m2 for Cycles 1-4

Also known as: Docetaxel injection

Trastuzumab Plus（+） Pertuzumab + Docetaxel; Trastuzumab Plus（+） QL1209 + Docetaxel

surgery PROCEDURE

All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.

Trastuzumab Plus（+） Pertuzumab + Docetaxel; Trastuzumab Plus（+） QL1209 + Docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in this clinical study; Completely understand and know this study as well as sign the informed consent form (ICF);
• Age ≥ 18 years and ≤ 80 years when ICF is signed;
• Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (\>) 2 centimeters (cm) by standard local assessment technique; Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0); HER2-positive breast cancer confirmed by immunohistochemistry or HER2 gene amplification by in situ hybridization; Estrogen receptor and Progesterone receptor negative.
• Eastern Cooperative Oncology Group Performance Status equal to or less than (\<=) 1.
• Baseline left ventricular ejection fracture \>= 55% measured by echocardiography (preferred) or multiple gated acquisition scan

You may not qualify if:

• Stage IV metastatic breast cancer;
• Inflammatory breast cancer;
• Previous anti-cancer therapy or radiotherapy for any malignancy;
• History of malignancies other than colorectal cancer within 5 years prior to randomization, excluding cutaneous basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary adenocarcinoma of non-melanoma after radical treatment;
• Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy;
• Major surgical procedure within 4 weeks prior to randomization or from which the participant has not fully recovered;
• Serious cardiac illness or medical condition;
• Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness;
• Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol;
• Pregnant or lactating

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 2000 32, China

Location

Tianjin Medical University Cancer Institution & Hospital

Tianjin, Tianjin Municipality, 300171, China

Location

Related Publications (1)

• Zuo W, Wang Z, Qian J, Ma X, Niu Z, Ou J, Mo Q, Sun J, Li X, Wang Q, Yao Y, Yu G, Li H, Chen D, Zhang H, Geng C, Qiao G, Zhao M, Zhang B, Kang X, Zhang J, Shao Z. QL1209 (pertuzumab biosimilar) versus reference pertuzumab plus trastuzumab and docetaxel in neoadjuvant treatment for HER2-positive, ER/PR-negative, early or locally advanced breast cancer: A multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial. Br J Cancer. 2024 Sep;131(4):668-675. doi: 10.1038/s41416-024-02751-2. Epub 2024 Jun 21.

  PMID: 38906970 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; pertuzumab; Docetaxel; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Zhimin Shao, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

• Jin Zhang, Professor

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 16, 2020
• Study Start: November 23, 2020
• Primary Completion: August 22, 2022
• Study Completion: October 24, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

CN (2)