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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhimin Shao, Professor | Fudan University | Principal Investigator |
| Jin Zhang, Professor | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | 2000 32 | China | ||
| Tianjin Medical University Cancer Institution & Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38906970 | Derived | 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. |
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Parallel Assignment
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|
| 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. |
|
|
| 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. |
|
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| Docetaxel | Drug | Docetaxel IV infusion in 3-week cycles. Neoadjuvant treatment: 75 mg/m2 for Cycles 1-4 |
|
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| surgery | Procedure | All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated. |
|
| At surgery |
| 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). | 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 | 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). | At surgery |
| 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. | Before surgery |
| Tianjin |
| Tianjin Municipality |
| 300171 |
| China |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| D000077143 | Docetaxel |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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