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Triple Negative Breast CancerPhase 3NCT03777579

A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC

A Phase 3 study testing JS001，an engineered anti-PD-1 antibody and Nab-Paclitaxel in people with Triple Negative Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage IV and recurrent or metastatic triple-negative breast cancer (TNBC)… 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?
JS001，an engineered anti-PD-1 antibody and Nab-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
375 participants
Where
1 siteChina
Study dates
21 Dec 2018to 30 Jul 2020
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primarily diagnosed stage IV or recurrent and metastatic, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression;
  • No prior chemotherapy or targeted systemic therapy for inoperable stage IV or metastatic TNBC；
  • Eligible for taxane monotherapy；
  • Eastern Cooperative Oncology Group performance status of 0 or 1；
  • Measurable disease as defined by RECIST v1.1；
  • Adequate hematologic and end-organ function。

Who cannot join

  • Known central nervous system (CNS) disease with active syndrome or untreated disease, except for treated asymptomatic CNS metastases；
  • History of autoimmune disease；
  • History of Anaphylaxis to PD-(L)1 antibody or CTLA-4 antibody or paclitaxel;
  • Prior allogeneic stem cell or solid organ transplantation;
  • Active hepatitis B or hepatitis C;
  • Positive of HIV antibody.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The fifth medical center of PLA general hospital

    Beijing

Other trials in China

About this study

Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001 (Anti-PD-1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel as First-line Therapy for Patients With Primarily Diagnose or Recurrent and Metastatic Triple-Negative Breast Cancer

This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage IV and recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).

Being tested
JS001，an engineered anti-PD-1 antibody, Nab-Paclitaxel, Placebo
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.

  • JS001，an engineered anti-PD-1 antibodyDrug

    Also called Terepril monoclonal antibody

    JS001 at a fixed dose of 240 milligrams via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.

  • Nab-PaclitaxelDrug

    Also called Paclitaxel For Injection（Albumin Bound）

    Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle. Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.

  • PlaceboDrug

    Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Study groups in NCT03777579
Study groupRoleWhat they receive
JS001 Plus Nab-PaclitaxelExperimentalParticipants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Receives: Drug: JS001，an engineered anti-PD-1 antibody; Drug: Nab-Paclitaxel
Placebo Plus Nab-PaclitaxelPlacebo comparatorParticipants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Receives: Drug: Nab-Paclitaxel; Drug: Placebo

What is being measured

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

  1. Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)

    PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.

    Measured: From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)

Secondary outcomes (13)

  1. Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator

    PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.

    Measured: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)

  2. Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC

    ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.

    Measured: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)

  3. Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC

    DoR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first.

    Measured: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)

  4. Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC

    DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.

    Measured: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)

  5. Overall Survival (OS)

    OS is defined as the time from randomization to death from any cause.

    Measured: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)

  6. OS rate at 12 months

    OS is defined as the time from randomization to death from any cause.

    Measured: the percent of participants that are alive at 12months from Day 1.

  7. OS rate at 24 months

    OS is defined as the time from randomization to death from any cause.

    Measured: the percent of participants that are alive at 24 months from Day 1.

  8. PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator

    Progression is confirmed in the target lesion category if the next imaging assessment after iUPD (4-8 weeks later) confirms a further increase in sum of measures of target disease from iUPD, with an increase of at least 5mm.

    Measured: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)

  9. ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator

    ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria.

    Measured: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)

  10. DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator

    DoR is defined as the time period from the date of initial iCR or iPR until the date of iCPD or death from any cause, whichever occurs first.

    Measured: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)

  11. DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator

    DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST.

    Measured: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)

  12. Percentage and severity of Participants With Adverse Events (AEs)

    percentage and CTC AE(v5.0) of AEs

    Measured: From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)

  13. Percentage of Participants With Anti-Drug Antibodies (ATAs)

    Measured: Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days)

Timeline

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

  1. First posted17 Dec 2018
  2. Study start21 Dec 2018
  3. Primary completion30 Dec 2019 (estimated)
  4. Study completion30 Jul 2020 (estimated)

Why it stopped: trial handovered to another sponser.

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
375 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03777579
Sponsor's protocol ID
NABP201801
Status last verified
Dec 2018
First submitted
12 Dec 2018
Last updated
8 Aug 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jiang Z, Ouyang Q, Sun T, Zhang Q, Teng Y, Cui J, Wang H, Yin Y, Wang X, Zhou X, Wang Y, Sun G, Wang J, Zhang L, Yang J, Qian J, Yan M, Liu X, Yi T, Cheng Y, Li M, Zang A, Wang S, Wang C, Wu X, Cheng J, Li H, Lin Y, Geng C, Gu K, Xie C, Xiong H, Wu X, Yang J, Li Q, Chen Y, Li F, Zhang A, Zhang Y, Wu Y, Nie J, Liu Q, Wang K, Mo X, Chen L, Pan Y, Fu P, Zhang H, Pang D, Sheng Y, Han Y, Wang H, Cang S, Luo X, Yu W, Deng R, Yang C, Keegan P. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: a randomized phase 3 trial. Nat Med. 2024 Jan;30(1):249-256. doi: 10.1038/s41591-023-02677-x. Epub 2024 Jan 8.

    PubMed 38191615

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JS001，an engineered anti-PD-1 antibody and Nab-Paclitaxel in people with Triple Negative Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology 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 6 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: paused, as of the sponsor's last update on 8 Aug 2019. 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. 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?

Results are not available in the source record.

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?

Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC) (time frame: From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)). 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 NCT03777579, 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 8 Aug 2019.

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