Clinical trial NCT04629846: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-16
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Volunteer to participate in this clinical study; Completely understand and know this study as well as sign the informed consent form (ICF);
2. Age ≥ 18 years and ≤ 80 years when ICF is signed;
3. 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.
4. Eastern Cooperative Oncology Group Performance Status equal to or less than (\<=) 1.
5. Baseline left ventricular ejection fracture \>= 55% measured by echocardiography (preferred) or multiple gated acquisition scan

Exclusion Criteria:

1. Stage IV metastatic breast cancer;
2. Inflammatory breast cancer;
3. Previous anti-cancer therapy or radiotherapy for any malignancy;
4. 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;
5. Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy;
6. Major surgical procedure within 4 weeks prior to randomization or from which the participant has not fully recovered;
7. Serious cardiac illness or medical condition;
8. Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness;
9. Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol;
10. Pregnant or lactating

Primary outcomes:
measure: Total pathologic complete response (tpCR) rate
timeFrame: Approximately 26 months after randomization of the first patient, when all patients have completed the treatment completion/discontinuation visit
Secondary outcomes:
measure: Percentage of Participants With tpCR as Assessed by the Local Pathologist
timeFrame: At surgery
measure: Percentage of Participants With Breast Pathologic Complete Response (bpCR) assessed by the IRC
timeFrame: Approximately 26 months after randomization of the first patient, when all patients have completed the treatment completion/discontinuation visit
measure: Percentage of Participants With bpCR as Assessed by the Local Pathologist
timeFrame: At surgery
measure: Percentage of Participants With an Objective Response
timeFrame: Before surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institution & Hospital
state: Tianjin
Study officials:
affiliation: Fudan University
name: Zhimin Shao, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Jin Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: