Breast CancerPhase 3NCT05629949
A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer
A Phase 3 study testing QL1701, Herceptin® and Docetaxel in people with Breast Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of QL1701 and Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- QL1701, Herceptin® and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2020to 13 Apr 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have voluntarily agreed to participate and given written informed consent.
- Female ≥18 years of age on day of signing the informed consent form (ICF).
- Histologically or cytologically confirmed adenocarcinoma of the breast that is HER2-positive by molecular pathology [IHC or fluorescence in situ hybridization (FISH)]; (4) Locally recurrent or metastatic breast cancer (including patients with first diagnosis of metastatic breast cancer) that cannot be treated with radical surgery or radiotherapy has an indication of taxane antitumor drug therapy regimen (according to the NCCN or Chinese treatment guidelines); (5) No systemic chemotherapy or targeted drug therapy for metastatic breast cancer has been performed in the past. If endocrine therapy has been performed, it must be stopped at least 2 weeks before enrollment; For patients who had received relevant neoadjuvant or adjuvant therapy in the past, HER2- related drugs should have been discontinued for at least 12 months before enrollment, and other non-HER2-related drugs should have been discontinued for at least 1 month before enrollment.
- There is at least one measurable lesion (non-bone metastatic lesion), which was evaluated according to RECIST 1.1 criteria.
Who cannot join
- Previous systemic chemotherapy or targeted drug therapy for metastatic breast cancer (including Herceptin ®, such as trastuzumab, pertuzumab, TDM-1, etc.; And non-herceptin ®, such as lapatinib, pyrrotinib, neratinib, etc.);
- Currently receiving other systemic antitumor therapies (such as chemotherapy and/or immunotherapy) or other therapies not specified in the study protocol that may affect the study;
- Use of other investigational drugs within 28 days before signing the informed consent;
- Definite confirmation of brain metastases (except those that have been evaluated asymptomatic or asymptomatic for at least 4 weeks after local lesion management and do not require steroid treatment);
- Have a history of other malignant tumors within 5 years before signing the informed consent, excluding cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has received radical treatment;
- Previous HIV infection or HIV screening positive, or HCV RNA positive, or syphilis antibody positive and active titer test;
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of QL1701 and Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.
Read the detailed description
This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of QL1701 and Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, recurrent or previously untreated metastatic breast cancer. Eligible patients will be assessed centrally for HER2 status and the presence of at least one measurable target lesion before randomization. Patients will undergo a tumor assessment for evaluation of response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) every 6 weeks up to 24 weeks (regardless of the number of cycles actually given);
- Conditions
- Breast Cancer
- Being tested
- QL1701, Herceptin®, Docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1701Drug
8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles.
Herceptin®Drug
8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles.
DocetaxelDrug
The recommended dose is 75mg/m2 and the infusion time is approximately 70min (±20min) (or adjusted according to clinical experience at each study center). The drug was administered once every 3 weeks for a treatment cycle of 3 weeks, with the exception of the second day of the first cycle, followed by the first day of each cycle for at least 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| QL1701+Docetaxel | Experimental | Participants received intravenous infusion of QL1701 with docetaxel. The initial load dose of QL1701 was 8mg/kg, followed by 6mg/kg every three weeks; The recommended dose of docetaxel is 75mg/m2, given once every 3 weeks for a treatment cycle of 3 weeks. Receives: Drug: QL1701; Drug: Docetaxel |
| Herceptin®+Docetaxel | Active comparator | Participants received intravenous infusion of Herceptin® with docetaxel. The initial load dose of Herceptin® was 8mg/kg, followed by 6mg/kg every three weeks; The recommended dose of docetaxel is 75mg/m2, given once every 3 weeks for a treatment cycle of 3 weeks. Receives: Drug: Herceptin®; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR at Week 24 by IRC
calculated as the proportion of patients with a best response of complete response (CR) or partial response (PR) from first assessment until Week 24 according to RECIST 1.1.
Measured: From time of First treatment to week 24
Secondary outcomes (5)
ORR at Week 24 by Investigator
alculated as the proportion of patients with a best response of complete response (CR) or partial response (PR) from first assessment until Week 24 according to RECIST 1.1.
Measured: From time of First treatment to week 24
PFS up to 12 months
The probability of being alive without documented progression up to 12 months after randomization
Measured: From time of first treatment to 12 months
DoR
The time from first documentation of CR or PR to the first documentation of progression
Measured: From time of first treatment to 12 months
DCR
The proportion of patients who achieve CR, PR, or stable disease (SD) of at least 12 weeks
Measured: From time of first treatment to 12 months
Overall survival at 12 months
the probability of being alive 12 months after randomization
Measured: From time of first treatment to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start29 Apr 2020
- Primary completion31 Dec 2022
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629949
- Sponsor's protocol ID
- QL1701-002
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05629949
- Acronym / sponsor ID
- QL1701-002
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of QL1701 and Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.
Detailed description
This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of QL1701 and Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, recurrent or previously untreated metastatic breast cancer. Eligible patients will be assessed centrally for HER2 status and the presence of at least one measurable target lesion before randomization. Patients will undergo a tumor assessment for evaluation of response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) every 6 weeks up to 24 weeks (regardless of the number of cycles actually given);
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1701+Docetaxel | Experimental | Drug: QL1701, Drug: DocetaxelParticipants received intravenous infusion of QL1701 with docetaxel. The initial load dose of QL1701 was 8mg/kg, followed by 6mg/kg every three weeks; The recommended dose of docetaxel is 75mg/m2, given once every 3 weeks for a treatment cycle of 3 weeks. |
| Herceptin®+Docetaxel | Active comparator | Drug: Herceptin®, Drug: DocetaxelParticipants received intravenous infusion of Herceptin® with docetaxel. The initial load dose of Herceptin® was 8mg/kg, followed by 6mg/kg every three weeks; The recommended dose of docetaxel is 75mg/m2, given once every 3 weeks for a treatment cycle of 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients have voluntarily agreed to participate and given written informed consent.
- Female ≥18 years of age on day of signing the informed consent form (ICF).
- Histologically or cytologically confirmed adenocarcinoma of the breast that is HER2-positive by molecular pathology [IHC or fluorescence in situ hybridization (FISH)]; (4) Locally recurrent or metastatic breast cancer (including patients with first diagnosis of metastatic breast cancer) that cannot be treated with radical surgery or radiotherapy has an indication of taxane antitumor drug therapy regimen (according to the NCCN or Chinese treatment guidelines); (5) No systemic chemotherapy or targeted drug therapy for metastatic breast cancer has been performed in the past. If endocrine therapy has been performed, it must be stopped at least 2 weeks before enrollment; For patients who had received relevant neoadjuvant or adjuvant therapy in the past, HER2- related drugs should have been discontinued for at least 12 months before enrollment, and other non-HER2-related drugs should have been discontinued for at least 1 month before enrollment.
Key exclusion criteria (6 listed)
- Previous systemic chemotherapy or targeted drug therapy for metastatic breast cancer (including Herceptin ®, such as trastuzumab, pertuzumab, TDM-1, etc.; And non-herceptin ®, such as lapatinib, pyrrotinib, neratinib, etc.);
- Currently receiving other systemic antitumor therapies (such as chemotherapy and/or immunotherapy) or other therapies not specified in the study protocol that may affect the study;
- Use of other investigational drugs within 28 days before signing the informed consent;
- Definite confirmation of brain metastases (except those that have been evaluated asymptomatic or asymptomatic for at least 4 weeks after local lesion management and do not require steroid treatment);
- Have a history of other malignant tumors within 5 years before signing the informed consent, excluding cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has received radical treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL17018 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles. | Drug | QL1701+Docetaxel |
| Herceptin®8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles. | Drug | Herceptin®+Docetaxel |
| DocetaxelThe recommended dose is 75mg/m2 and the infusion time is approximately 70min (±20min) (or adjusted according to clinical experience at each study center). The drug was administered once every 3 weeks for a treatment cycle of 3 weeks, with the exception of the second day of the first cycle, followed by the first day of each cycle for at least 8 cycles | Drug | Herceptin®+Docetaxel, QL1701+Docetaxel |
Primary outcome
ORR at Week 24 by IRC
Time frame: From time of First treatment to week 24
calculated as the proportion of patients with a best response of complete response (CR) or partial response (PR) from first assessment until Week 24 according to RECIST 1.1.
5 secondary outcomes
ORR at Week 24 by Investigator
Time frame: From time of First treatment to week 24
PFS up to 12 months
Time frame: From time of first treatment to 12 months
DoR
Time frame: From time of first treatment to 12 months
DCR
Time frame: From time of first treatment to 12 months
Overall survival at 12 months
Time frame: From time of first treatment to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QL1701, Herceptin® and Docetaxel in people with Breast Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site 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 4 inclusion and 6 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 23 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 1 site 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?
ORR at Week 24 by IRC (time frame: From time of First treatment to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2024.