Clinical trial · Interventional
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.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| QL1209 | Drug | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Trastuzumab Plus(+) QL1209 + Docetaxel
- description
- Prior to surgery: trastuzumab, QL1209, and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: QL1209 Drug: Trastuzumab Procedure: Surgery
- interventionNames
- Drug: Trastuzumab
- Drug: QL1209
- Drug: Docetaxel
- Procedure: surgery
- type
- ACTIVE_COMPARATOR
- label
- Trastuzumab Plus(+) Pertuzumab + Docetaxel
- description
- Prior to surgery: trastuzumab,pertuzumab , and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: Pertuzumab Drug: Trastuzumab Procedure: Surgery
- interventionNames
- Drug: Trastuzumab
- Drug: Pertuzumab
- Drug: Docetaxel
- Procedure: surgery
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZuo 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