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AzTrials

Breast CancerPhase 3NCT04629846

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 Phase 3 study testing Trastuzumab, QL1209 and Pertuzumab in people with Breast Cancer, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab, QL1209 and Pertuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
517 participants
Where
2 sitesChina
Study dates
23 Nov 2020to 24 Oct 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 2000 32

  • Tianjin Medical University Cancer Institution & Hospital

    Tianjin, Tianjin Municipality, 300171

Other trials in China

About this study

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.

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Trastuzumab, QL1209, Pertuzumab, Docetaxel, surgery
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrastuzumabDrug

    Also called Herceptin®

    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.

  • QL1209Drug

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

    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.

  • PertuzumabDrug

    Also called Perjeta®

    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.

  • DocetaxelDrug

    Also called Docetaxel injection

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

  • surgeryProcedure or surgery

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

Study groups in NCT04629846
Study groupRoleWhat they receive
Trastuzumab Plus（+） QL1209 + DocetaxelExperimentalPrior to surgery: trastuzumab, QL1209, and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: QL1209 Drug: Trastuzumab Procedure: Surgery
Receives: Drug: Trastuzumab; Drug: QL1209; Drug: Docetaxel; Procedure: surgery
Trastuzumab Plus（+） Pertuzumab + DocetaxelActive comparatorPrior to surgery: trastuzumab,pertuzumab , and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: Pertuzumab Drug: Trastuzumab Procedure: Surgery
Receives: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel; Procedure: surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

Secondary outcomes (4)

  1. 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).

    Measured: At surgery

  2. 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).

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

  3. 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).

    Measured: At surgery

  4. 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.

    Measured: Before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2020
  2. Study start23 Nov 2020
  3. Primary completion22 Aug 2022
  4. Study completion24 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
517 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04629846
Sponsor's protocol ID
QL1209-301
Status last verified
Apr 2024
First submitted
28 Oct 2020
Last updated
19 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38906970

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab, QL1209 and Pertuzumab in people with Breast Cancer, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total pathologic complete response (tpCR) rate (time frame: Approximately 26 months after randomization of the first patient, when all patients have completed the treatment completion/discontinuation visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04629846, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.

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