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Triple Negative Breast CancerPhase 2NCT05174832

Induction of Cisplatin/Nab-paclitaxel/Pembrolizumab Followed by Olaparib/Pembrolizumab Maintenance in mTNBC Patients

A Phase 2 study testing Cisplatin, Nab-paclitaxel and Pembrolizumab in people with Triple Negative Breast Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to investigate if olaparib plus pembrolizumab will maintain the clinical benefit achieved after induction therapy with Albumin-bound paclitaxel combined with cisplatin(AP) regimen and pembrolizumab in previously untreated locally advanced, recurrent or metastatic TNBC population with PD-L1 CPS≥1. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Cisplatin, Nab-paclitaxel and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteChina
Study dates
7 Sep 2022to 1 Mar 2025
Phase
Phase 2
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

  • Induction period:
  • Locally advanced, recurrent or metastatic TNBC that has not been treated with chemotherapy for the advanced disease. Local or distant disease recurrence must be≥6 months from the completion of the last dose of chemotherapy.
  • PD-L1 CPS≥1 and ER and PR negative, HER2 negative breast cancer.
  • Archival tumor tissue sample or newly obtained core or excisional biopsy sample
  • Measurable disease based on RECIST 1.1.
  • ECOG Performance Status 0-1
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  • Life expectancy≥18 weeks
  • Adequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 10 days prior to start of study treatment)
  • Maintenance period：
  • Complete induction therapy without permanent discontinuation of pembrolizumab, nab-paclitaxel or cisplatin.
  • CR, PR, or SD status based on RECIST 1.1 as determined by local investigators.
  • ECOG Performance Status 0-1, as assessed within 7 days prior to the start of maintenance therapy.
  • Recovery of toxicities related to induction therapy to ≤ grade 1 (except alopecia) prior to randomization. Grade 2 neuropathy will be allowed, whereas grade 2 hyperthyroidism or hypothyroidism will also be allowed if it can be well controlled with medicines.

Who cannot join

  • Induction period:
  • Has received any prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
  • Has received any prior therapy with either olaparib or other PARP inhibitors.
  • Has received any prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
  • Has received prior radiotherapy within 2 weeks of start of study treatment
  • Has received a live vaccine within 30 days prior to the first dose of study drug
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  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, cervical cancer in situ) that have undergone potentially curative therapy
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has a known history of hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipient
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years
  • Has gastrointestinal impairment that could affect their ability to take or absorb oral medicines; evidence of severe or uncontrolled cardiac disease; active bleeding or bleeding diathesis defined as significant hemorrhage; or hemoptysis.
  • Has a resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions or has congenital long QT syndrome.
  • Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
  • Has a history of (non-infectious) pneumonitis that required treatment with steroids; or current pneumonitis.
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of active Hepatitis B or known active Hepatitis C virus infection
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  • Has been pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of trial treatment.
  • Has had an allogenic tissue/solid organ transplant.
  • Failure to comply with the study procedures, restrictions and requirements of the study
  • Maintenance period：
  • Has permanently discontinued from nab-paclitaxel, cisplatin or pembrolizumab during induction period due to toxicity.
  • Currently receiving either strong or moderated inhibitors of cytochrome P450 (CYP) 3A4 that cannot be discontinued for the duration of the study.
  • Currently receiving either strong or moderate inducers of CYP3A4 that cannot be discontinued for the duration of the study.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Chengcheng Gong, M.D., 021-54561523, ccgongfuscc@163.com

    Recruiting

Other trials in China

About this study

Official title: Induction of Cisplatin/Nab-paclitaxel/Pembrolizumab Followed by Olaparib/Pembrolizumab Maintenance in Triple-negative Metastatic Breast Cancer Patients

This study aims to investigate if olaparib plus pembrolizumab will maintain the clinical benefit achieved after induction therapy with Albumin-bound paclitaxel combined with cisplatin(AP) regimen and pembrolizumab in previously untreated locally advanced, recurrent or metastatic TNBC population with PD-L1 CPS≥1.

Read the detailed description

TNBC is a hard-to-treat disease requiring continuous administration of drugs, necessitating further exploration of optimal maintenance strategy. However, there are currently no standard maintenance treatment regimens in the treatment of mTNBC. KEYNOTE-355 has already proved pembrolizumab has durable antitumor activity and manageable safety in patients with metastatic TNBC. Olaparib is now established as maintenance therapy for platinum-sensitive populations regardless of BRCA status in the setting of other tumor types. Furthermore, preclinical and clinical data indicates that olaparib and pembrolizumab combination have an improved therapeutic effect, showing promising synergistic benefits. Therefore, adding olaparib to pembrolizumab after induction treatment with a platinum-based regimen plus pembrolizumab will high likely change and expand the treatment paradigm in this disease, particularly for those patients with platinum-sensitive TNBC tumors. Olaparib plus pembrolizumab has the potential for further treatment benefit as a chemo-sparing regimen.

Keywords
Pembrolizumab, Olaparib, Platinum-based chemotherapy, Triple negative breast cancer
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.

  • CisplatinDrug

    75 mg/m2 IV days 1 of each 21-day cycle

  • Nab-paclitaxelDrug

    125 mg/m2 IV days 1 and 8 of each 21-day cycle

  • PembrolizumabDrug

    Also called keytruda

    200 mg IV every 21 days

  • OlaparibDrug

    Also called LYNPARZA

    300 mg PO BID

Study groups in NCT05174832
Study groupRoleWhat they receive
Cisplatin+ Nab-paclitaxel + Pembrolizumab followed by Pembrolizumab monotherapyActive comparator4~6 cycles combination therapy of Cisplatin, Nab-paclitaxel and Pembrolizumab as induction therapy; Pembrolizumab monotherapy as maintenance therapy
Receives: Drug: Cisplatin; Drug: Nab-paclitaxel; Drug: Pembrolizumab
Cisplatin+Nab-paclitaxel+Pembrolizumab followed by Pembrolizumab+OlaparibExperimental4~6 cycles combination therapy of Cisplatin, Nab-paclitaxel and Pembrolizumab as induction therapy; Pembrolizumab plus Olaparib as maintenance therapy
Receives: Drug: Cisplatin; Drug: Nab-paclitaxel; Drug: Pembrolizumab; Drug: Olaparib

What is being measured

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

  1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by local investigators

    PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 36 months

Secondary outcomes (9)

  1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators

    PFS is defined as the time from enrollment data (informed consent date) to the first documented disease or death due to any cause, whichever occurs first.

    Measured: Up to 36 months

  2. Overall Survival (OS)

    OS is defined as the time from enrollment date to death due to any cause.

    Measured: Up to 36 months

  3. Objective Response Rate(ORR) in induction and maintenance phase

    ORR is defined as the proportion of the total number of subjects with a confirmed CR or confirmed PR

    Measured: Up to approximately 36 months

  4. Progression-Free Survival (PFS) in gBRCAm and gBRCAwt participants

    PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 36 months

  5. Overall Survival (OS) in gBRCAm and gBRCAwt participants

    OS: the time from randomization to death due to any cause.

    Measured: Up to approximately 36 months

  6. Progression-Free Survival (PFS) in HRR deficient participants

    PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 36 months

  7. Overall Survival (OS) in HRR deficient participants

    OS: the time from randomization to death due to any cause.

    Measured: Up to approximately 36 months

  8. Overall Survival (OS)

    OS: the time from randomization to death due to any cause.

    Measured: Up to approximately 36 months

  9. Number of Participants with Treatment Related Adverse Events

    AEs assessed by CTCAE V5.0

    Measured: Up to approximately 36 months

Timeline

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

  1. First posted3 Jan 2022
  2. Study start7 Sep 2022
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Mar 2025 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05174832
Sponsor's protocol ID
COMPLEMENT
Status last verified
Nov 2022
First submitted
13 Dec 2021
Last updated
28 Sep 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, Nab-paclitaxel and Pembrolizumab in people with Triple Negative Breast Cancer, run by Fudan University 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 13 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by local investigators (time frame: Up to 36 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 NCT05174832.

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 28 Sep 2023.

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