A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer

NCT05629949 | Completed Phase 3

• 1 other identifier: QL1701-002
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of QL1701 and Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• ORR at Week 24 by IRC

  calculated as the proportion of patients with a best response of complete response (CR) or partial response (PR) from first assessment until Week 24 according to RECIST 1.1.

  From time of First treatment to week 24

Secondary Outcomes (5)

• ORR at Week 24 by Investigator

  From time of First treatment to week 24

• PFS up to 12 months

  From time of first treatment to 12 months

• DoR

  From time of first treatment to 12 months

• DCR

  From time of first treatment to 12 months

• Overall survival at 12 months

  From time of first treatment to 12 months

Study Arms (2)

QL1701+Docetaxel

EXPERIMENTAL

Participants received intravenous infusion of QL1701 with docetaxel. The initial load dose of QL1701 was 8mg/kg, followed by 6mg/kg every three weeks; The recommended dose of docetaxel is 75mg/m2, given once every 3 weeks for a treatment cycle of 3 weeks.

Drug: QL1701; Drug: Docetaxel

Herceptin®+Docetaxel

ACTIVE COMPARATOR

Participants received intravenous infusion of Herceptin® with docetaxel. The initial load dose of Herceptin® was 8mg/kg, followed by 6mg/kg every three weeks; The recommended dose of docetaxel is 75mg/m2, given once every 3 weeks for a treatment cycle of 3 weeks.

Drug: Herceptin®; Drug: Docetaxel

Interventions

QL1701 DRUG

8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles.

QL1701+Docetaxel

Herceptin® DRUG

8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles.

Herceptin®+Docetaxel

Docetaxel DRUG

The recommended dose is 75mg/m2 and the infusion time is approximately 70min (±20min) (or adjusted according to clinical experience at each study center). The drug was administered once every 3 weeks for a treatment cycle of 3 weeks, with the exception of the second day of the first cycle, followed by the first day of each cycle for at least 8 cycles

Herceptin®+Docetaxel; QL1701+Docetaxel

Eligibility Criteria

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

You may qualify if:

• Patients have voluntarily agreed to participate and given written informed consent.
• Female ≥18 years of age on day of signing the informed consent form (ICF).
• Histologically or cytologically confirmed adenocarcinoma of the breast that is HER2-positive by molecular pathology \[IHC or fluorescence in situ hybridization (FISH)\]; (4) Locally recurrent or metastatic breast cancer (including patients with first diagnosis of metastatic breast cancer) that cannot be treated with radical surgery or radiotherapy has an indication of taxane antitumor drug therapy regimen (according to the NCCN or Chinese treatment guidelines); (5) No systemic chemotherapy or targeted drug therapy for metastatic breast cancer has been performed in the past. If endocrine therapy has been performed, it must be stopped at least 2 weeks before enrollment; For patients who had received relevant neoadjuvant or adjuvant therapy in the past, HER2- related drugs should have been discontinued for at least 12 months before enrollment, and other non-HER2-related drugs should have been discontinued for at least 1 month before enrollment.
• There is at least one measurable lesion (non-bone metastatic lesion), which was evaluated according to RECIST 1.1 criteria.

You may not qualify if:

• Previous systemic chemotherapy or targeted drug therapy for metastatic breast cancer (including Herceptin ®, such as trastuzumab, pertuzumab, TDM-1, etc.; And non-herceptin ®, such as lapatinib, pyrrotinib, neratinib, etc.);
• Currently receiving other systemic antitumor therapies (such as chemotherapy and/or immunotherapy) or other therapies not specified in the study protocol that may affect the study;
• Use of other investigational drugs within 28 days before signing the informed consent;
• Definite confirmation of brain metastases (except those that have been evaluated asymptomatic or asymptomatic for at least 4 weeks after local lesion management and do not require steroid treatment);
• Have a history of other malignant tumors within 5 years before signing the informed consent, excluding cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has received radical treatment;
• Previous HIV infection or HIV screening positive, or HCV RNA positive, or syphilis antibody positive and active titer test;

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital,Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Docetaxel

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 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

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 29, 2022
• Study Start: April 29, 2020
• Primary Completion: December 31, 2022
• Study Completion: April 13, 2023
• Last Updated: April 23, 2024

Record last verified: 2022-11

Locations

CN (1)