Triple Negative Breast CancerPhase 3NCT04301739
to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC)
A Phase 3 study testing HLX10 and nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide in people with Triple Negative Breast Cancer, run by Shanghai Henlius Biotech.
Trial summary
This study is a randomized, double-Blind,international multi-Centre, phase III clinical study to evaluate efficacy and safety of HLX10 in combination with chemotherapy versus placebo in combination with chemotherapy as neoadjuvant therapy and HLX10 versus placebo as adjuvant therapy in previously untreated and… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- HLX10 and nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 522 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2020to 9 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects histologically diagnosed with previously untreated TNBC (lack of human epidermal growth factor receptor-2 [HER2], estrogen receptor [ER], progesterone receptor expression as determined by the study site).
- Subjects who are judged as one of the following by the American Joint Committee on Cancer (AJCC) within 4 weeks prior to randomisation:
- T1c, N1-N2, M0
- T2, N0-N2, M0
- T3, N0-N2, M0
- T4a-c, N0-N2, M0.
- Major organs are functioning well
- Participant must keep contraception
Who cannot join
- Subjects with any other active malignancy within 5 years prior to signing the informed consent form or at the same time. Localised tumours that have been cured such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder carcinoma, and cervical cancer in situ are acceptable.
- Subjects who have received chemotherapy, targeted therapy, or radiotherapy within 12 months prior to the initial dose of the investigational product.
- Subjects with a history of severe allergy to any monoclonal antibody or investigational product and its excipient.
- Pregnant or lactating women.
- Subjects with a known history of psychotropics abuse or drug abuse
- Subjects presenting other factors not suitable for participation as judged by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, International Multi-Centre, Phase III Clinical Study to Evaluate Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC)
This study is a randomized, double-Blind,international multi-Centre, phase III clinical study to evaluate efficacy and safety of HLX10 in combination with chemotherapy versus placebo in combination with chemotherapy as neoadjuvant therapy and HLX10 versus placebo as adjuvant therapy in previously untreated and potentially resectable patients with TNBC and without distant metastasis.
Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:
Arm A (HLX10 arm): HLX10 + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → HLX10 + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → HLX10 (9 cycles) Arm B (placebo arm): Placebo + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → Placebo + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → Placebo (9 cycles) The three stratification factors for randomization include: lymph node metastasis (yes or no), size of primary tumor lesion (T1/T2 or T3/T4), asian population (yes or no).
- Conditions
- Triple Negative Breast Cancer
- Being tested
- HLX10, nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide, Placebo
- Keywords
- Triple Negative Breast Cancer, Previously Untreated, Potentially Resectable, Without Distant Metastasis
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX10Drug
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamideDrug
chemotherapeutics
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| HLX10 + chemotherapy→ HLX10 | Experimental | HLX10 + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → HLX10 + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → HLX10 (9 cycles) Receives: Drug: HLX10; Drug: nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide |
| Placebo + chemotherapy→ Placebo | Placebo comparator | Placebo + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → Placebo + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → Placebo (9 cycles) Receives: Drug: nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor assessment
Pathological complete response (pCR) rate (ypT0/Tis, ypN0) (assessed by central pathology laboratory based on American Joint Committee on Cancer (AJCC) staging system)
Measured: up till 5 years after the enroll
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start17 Apr 2020 (estimated)
- Primary completion7 Sep 2022 (estimated)
- Study completion9 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 522 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301739
- Sponsor's protocol ID
- HLX10-013-TNBCneo
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, International Multi-Centre, Phase III Clinical Study to Evaluate Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT04301739
- Acronym / sponsor ID
- HLX10-013-TNBCneo
- Conditions
- Triple Negative Breast Cancer
- Keywords
- Triple Negative Breast Cancer, Previously Untreated, Potentially Resectable, Without Distant Metastasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 522 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2020 (estimated)
- Primary completion
- 7 Sep 2022 (estimated)
- Study completion
- 9 Apr 2027 (estimated)
- First posted
- 10 Mar 2020 (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 study is a randomized, double-Blind,international multi-Centre, phase III clinical study to evaluate efficacy and safety of HLX10 in combination with chemotherapy versus placebo in combination with chemotherapy as neoadjuvant therapy and HLX10 versus placebo as adjuvant therapy in previously untreated and potentially resectable patients with TNBC and without distant metastasis.
Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:
Arm A (HLX10 arm): HLX10 + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → HLX10 + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → HLX10 (9 cycles) Arm B (placebo arm): Placebo + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → Placebo + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → Placebo (9 cycles) The three stratification factors for randomization include: lymph node metastasis (yes or no), size of primary tumor lesion (T1/T2 or T3/T4), asian population (yes or no).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLX10 + chemotherapy→ HLX10 | Experimental | Drug: HLX10, Drug: nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamideHLX10 + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → HLX10 + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → HLX10 (9 cycles) |
| Placebo + chemotherapy→ Placebo | Placebo comparator | Drug: nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide, Drug: PlaceboPlacebo + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → Placebo + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → Placebo (9 cycles) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects histologically diagnosed with previously untreated TNBC (lack of human epidermal growth factor receptor-2 [HER2], estrogen receptor [ER], progesterone receptor expression as determined by the study site).
- Subjects who are judged as one of the following by the American Joint Committee on Cancer (AJCC) within 4 weeks prior to randomisation:
- Major organs are functioning well
- Participant must keep contraception
Key exclusion criteria (6 listed)
- Subjects with any other active malignancy within 5 years prior to signing the informed consent form or at the same time. Localised tumours that have been cured such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder carcinoma, and cervical cancer in situ are acceptable.
- Subjects who have received chemotherapy, targeted therapy, or radiotherapy within 12 months prior to the initial dose of the investigational product.
- Subjects with a history of severe allergy to any monoclonal antibody or investigational product and its excipient.
- Pregnant or lactating women.
- Subjects with a known history of psychotropics abuse or drug abuse
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 |
|---|---|---|
| HLX10HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. | Drug | HLX10 + chemotherapy→ HLX10 |
| nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamidechemotherapeutics | Drug | HLX10 + chemotherapy→ HLX10, Placebo + chemotherapy→ Placebo |
| PlaceboPlacebo | Drug | Placebo + chemotherapy→ Placebo |
Primary outcome
tumor assessment
Time frame: up till 5 years after the enroll
Pathological complete response (pCR) rate (ypT0/Tis, ypN0) (assessed by central pathology laboratory based on American Joint Committee on Cancer (AJCC) staging system)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HLX10 and nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide in people with Triple Negative Breast Cancer, run by Shanghai Henlius Biotech.
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 8 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: opening soon, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tieshuang Chi, Master (+8618621117100, olivia_chi@henlius.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor assessment (time frame: up till 5 years after the enroll). 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 12 Mar 2020.