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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.

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Trastuzumab

QL1209

Pertuzumab

Docetaxel

surgery

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Fudan University Cancer Hospital
Tianjin Medical University Cancer Institution & Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trastuzumab Plus（+） QL1209 + Docetaxel

Trastuzumab Plus（+） Pertuzumab + Docetaxel

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Percentage of Participants With tpCR as Assessed by the Local Pathologist

This tpCR was assessed by the local pathologist. tpCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer [AJCC] staging system).

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

This bpCR was assessed by the IRC. bpCR is defined as the absence of any residual invasive cancer on the hematoxylin and eosin evaluation of the resected breast specimen after completion of neoadjuvant therapy and surgery (that is, ypT0/is, in accordance with current AJCC staging system).

Percentage of Participants With bpCR as Assessed by the Local Pathologist

This bpCR was assessed by the local pathologist. bpCR is defined as the absence of any residual invasive cancer on the hematoxylin and eosin evaluation of the resected breast specimen after completion of neoadjuvant therapy and surgery (that is, ypT0/is in accordance with current AJCC staging system).

Percentage of Participants With an Objective Response

An objective response was defined as the percentage of participants who achieved a complete response or partial response as the best tumor response during the neoadjuvant period (that is, during Cycles 1-4 prior to surgery), as determined by the investigator on the basis of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. No confirmation was required for objective response. Only participants with measurable disease at baseline were included in the analysis. The duration of one treatment cycle is 21 days; the administration of therapy in Cycle 5 should not occur until 2 weeks after surgery.

Full Information

NCT ID

NCT04629846

First Posted

October 28, 2020

Last Updated

November 10, 2020

Sponsor

Qilu Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04629846

Brief Title

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.

Official Title

A Randomized, Multicenter, Double-Blind, Parallel-Controlled, Phase III Clinical Study to Evaluate QL1209/Pertuzumab in Combination With Docetaxel in Patients With Early-Stage or Locally Advanced HER2-Positive and ER/PR-negative Breast Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 2020 (Anticipated)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

This is A multi-center, randomized, double-blind, parallel control，comparative clinical trial. The primary objective is to evaluate whether the clinical efficacy of QL1209 and pertuzumab are similar in patients with early-stage or locally advanced HER2-positive and estrogen receptor/progesterone receptor negative breast cancer. The secondary objective are to evaluate whether the clinical safety and immunogenicity of QL1209 and pertuzumab are similar in patients with early-stage or locally advanced HER2-positive and estrogen receptor/progesterone receptor negative breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

544 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trastuzumab Plus（+） QL1209 + Docetaxel

Arm Type

Experimental

Arm Description

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

Arm Title

Trastuzumab Plus（+） Pertuzumab + Docetaxel

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Other Intervention Name(s)

Herceptin®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

QL1209

Other Intervention Name(s)

Recombinant anti-HER-2 domain Ⅱ humanized monoclonal antibody injection

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pertuzumab

Other Intervention Name(s)

Perjeta®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Docetaxel injection

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

surgery

Intervention Description

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

Primary Outcome Measure Information:

Title

Total pathologic complete response (tpCR) rate

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Percentage of Participants With tpCR as Assessed by the Local Pathologist

Description

Time Frame

At surgery

Title

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

Description

Time Frame

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

Title

Percentage of Participants With bpCR as Assessed by the Local Pathologist

Description

Time Frame

At surgery

Title

Percentage of Participants With an Objective Response

Description

Time Frame

Before surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qixian Kong, CMO

Phone

0531-83129659

oliver.kong@qilu-pharma.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhimin Shao, Professor

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jin Zhang, Professor

Organizational Affiliation

Tianjin Medical University Cancer Institute & Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Cancer Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

2000 32

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhimin Shao, Professor

First Name & Middle Initial & Last Name & Degree

Zhimin Shao, Professor

Facility Name

Tianjin Medical University Cancer Institution & Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300171

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Zhang, Professor

First Name & Middle Initial & Last Name & Degree

Jin Zhang, Professor

12. IPD Sharing Statement

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