Recurrent Triple-Negative Breast CancerPhase 2PRELUDENCT06976944
Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer
A Phase 2 study testing Pembrolizumab, Paclitaxel and Bevacizumab in people with Recurrent Triple-Negative Breast Cancer, run by Yukinori Ozaki at 14 sites in Japan.
Trial summary
Breast cancer is histologically divided into non-invasive (approximately 10%) and invasive (approximately 90%), with invasive cancer being the target of chemotherapy. Invasive carcinoma is classified into four subtypes according to the expression levels of hormone receptor (HR) and human epidermal growth factor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Triple-Negative Breast Cancer
- What is being tested?
- Pembrolizumab, Paclitaxel and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 14 sitesJapan
- Study dates
- 24 Jun 2025to Sep 2029
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female participants who are 18 years of age or older on the day of signing informed consent with histologically or cytologically confirmed diagnosis of invasive breast cancer will be enrolled in this study.
- Participants have been confirmed to be ER negative, HER2 negative according to the latest ASCO/CAP criteria. However, it does not matter whether the result is positive or negative for PgR.
- Participants have been confirmed to be PD-L1 positive in each site's evaluation using biopsy specimen or surgical specimen.
- Participants who have received not more than 1 prior chemotherapy regimen (including those with no prior chemotherapy) for recurrent breast cancer, excluding trial drugs of this clinical trial. (Participants with prior paclitaxel or bevacizumab for recurrent breast cancer are excluded.) However, prior treatment with Olaparib for metastatic recurrence or unresectable advanced cancer in participants with BRCA gene pathogenic variant is allowed (not counted as 1 regimen).
- Participants must have recurred after treatment with an anti-PD-1/PD-L1 antibody administered as monotherapy or in combination with other ICIs or chemotherapies as a perioperative drug therapy for triple negative breast cancer.
- Have an Eastern Cooperative Oncology Group performance status of 0 to 1.
Who cannot join
- Participants with progressive disease on RECIST or clinically diagnosed during preoperative ICI and chemotherapy.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years prior to enrollment.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Japan14 sites, 14 recruiting
- Recruiting
Hyogo Cancer Center
Akashi-shi, Hyōgo, 673-8558
Koji Matsumoto, +81-78-929-1151
Koji Matsumoto
- Recruiting
Gifu University Hospital
Gifu, Gifu, 501-1194
Manabu Futamura, +81-58-230-6000
Manabu Futamura
- Recruiting
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Hideo Shigematsu, +81-82-257-5555
Hideo Shigematsu
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
Chikako Funasaka, +81-4-7133-1111
Chikako Funasaka
- Recruiting
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Toshimi Takano, +81-3-3520-0111
Yukinori Ozaki
- Recruiting
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001
Chiyoe Kitagawa, +81-52-951-1111
Chiyoe Kitagawa
- Recruiting
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Madoka Iwase, +81-52-741-2111
Madoka Iwase
- Recruiting
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Kazuki Nozawa, +81-52-851-5511
Kazuki Nozawa
- Recruiting
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Yuko Takahashi, +81-86-235-6835
Yuko Takahashi
- Recruiting
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Takahiro Nakayama, +81-6-6945-1181
Takahiro Nakayama
- Recruiting
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-0051
Shinichiro Kashiwagi, +81-6-6645-2121
Shinichiro Kashiwagi
- Recruiting
Kindai University Hospital
Sakai-shi, Osaka, 590-0197
Satomi Watanabe, +81-72-288-7222
Satomi Watanabe
- Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Tomohiro Oshino, +81-11-716-1161
Tomohiro Oshino
- Recruiting
SHOWA Medical University Hospital
Shinagawa-ku, Tokyo, 142-8666
Hitomi Sakai, +81-3-3784-8000
Hitomi Sakai
About this study
Official title: Randomized Phase II Study of Pembrolizumab + Paclitaxel +/- Bevacizumab in Patients With Recurrent Triple-Negative Breast Cancer Who Received Perioperative Immunotherapy
- Breast cancer is histologically divided into non-invasive (approximately 10%) and invasive (approximately 90%), with invasive cancer being the target of chemotherapy. Invasive carcinoma is classified into four subtypes according to the expression levels of hormone receptor (HR) and human epidermal growth factor receptor type 2 (HER2). Among them, triple negative breast cancer accounts for 10% of invasive cancers and is the subtype with the poorest prognosis.
- For triple negative breast cancer that is operable, chemotherapy with pembrolizumab is administered either preoperatively or postoperatively (perioperative period). For recurrent triple negative breast cancer , combination chemotherapy with multiple agents is the standard of care, especially in the case of PD-L1-positive patients, chemotherapy with an immune checkpoint inhibitor related to PD-1 (pembrolizumab or atezolizumab) is administered.
- Although the KEYNOTE355 trial demonstrated the efficacy of pembrolizumab plus paclitaxel therapy in patients with PD-L1-positive triple negative breast cancer in postoperative relapse, this trial did not include patients who received pembrolizumab in the perioperative period. Therefore, it is not known if there is any benefit to re-administering pembrolizumab to these patients after relapse.
- Bevacizumab is used as standard therapy for triple negative breast cancer in combination with paclitaxel. Bevacizumab itself is an anti-tumor agent that inhibits angiogenesis, but has also been reported to activate immunity against cancer, suggesting that it may enhance the effect of pembrolizumab.
Based on the above, the investigators planned this trial to evaluate whether pembrolizumab + paclitaxel + bevacizumab therapy is more effective than pembrolizumab + paclitaxel therapy in PD-L1-positive triple negative breast cancer patients who relapse after receiving immune checkpoint inhibitors in the perioperative period.
- Conditions
- Recurrent Triple-Negative Breast Cancer
- Being tested
- Pembrolizumab, Paclitaxel, Bevacizumab
- Keywords
- Recurrent Triple-Negative, Breast Cancer, checkpoint inhibitor, angiogenesis inhibitor
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Protocol treatment will continue until worsening of the participant's underlying disease or unacceptable toxicity is observed or the participant withdraws the consent, or the participant meets other discontinuation criteria.
Pembrolizumab: Intravenous infusion(400 mg/body, every 6 weeks starting on Day 1 of Cycle 1)
PaclitaxelDrug
Protocol treatment will continue until worsening of the participant's underlying disease or unacceptable toxicity is observed or the participant withdraws the consent, or the participant meets other discontinuation criteria.
Paclitaxel: Intravenous infusion(90 mg/m^2, on Days 1, 8, and 15, starting on Day 1 of Cycle 1 with a 28-day cycle)
BevacizumabDrug
Protocol treatment will continue until worsening of the participant's underlying disease or unacceptable toxicity is observed or the participant withdraws the consent, or the participant meets other discontinuation criteria.
Bevacizumabl: Intravenous infusion(10 mg/kg, on Days 1, and 15, starting on Day 1 of Cycle 1 with a 28-day cycle)
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + paclitaxel + bevacizumab | Experimental | Not described Receives: Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Bevacizumab |
| Pembrolizumab + paclitaxel | Active comparator | Not described Receives: Drug: Pembrolizumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: Through protocol treatment discontinuation, approximately 9 months
Secondary outcomes (4)
Overall response rate
Measured: Through protocol treatment discontinuation, approximately 9 months
Overall survival
Measured: Through study completion, approximately 3.5 years
Disease control rate
Measured: Through protocol treatment discontinuation, approximately 9 months
Incidence of adverse events
Measured: Until 1 month after protocol treatment discontinuation, approximately 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start24 Jun 2025
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Triple-Negative Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yukinori Ozaki
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Yukinori Ozaki, Japanese Foundation for Cancer Research
- Investigators
- Toshimi Takano, Study chair, Cancer Institute Hospital of JFCR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976944
- Sponsor's protocol ID
- WJOG16522B
- Other IDs
- jRCT2031250076
- Acronym
- PRELUDE
- Status last verified
- Jul 2026
- First submitted
- 30 Apr 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Pembrolizumab + Paclitaxel +/- Bevacizumab in Patients With Recurrent Triple-Negative Breast Cancer Who Received Perioperative Immunotherapy
- ClinicalTrials.gov ID
- NCT06976944
- Acronym / sponsor ID
- PRELUDE / WJOG16522B
- Conditions
- Recurrent Triple-Negative Breast Cancer
- Keywords
- Recurrent Triple-Negative, Breast Cancer, checkpoint inhibitor, angiogenesis inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Yukinori OzakiUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 16 May 2025 (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.
- Breast cancer is histologically divided into non-invasive (approximately 10%) and invasive (approximately 90%), with invasive cancer being the target of chemotherapy. Invasive carcinoma is classified into four subtypes according to the expression levels of hormone receptor (HR) and human epidermal growth factor receptor type 2 (HER2). Among them, triple negative breast cancer accounts for 10% of invasive cancers and is the subtype with the poorest prognosis.
- For triple negative breast cancer that is operable, chemotherapy with pembrolizumab is administered either preoperatively or postoperatively (perioperative period). For recurrent triple negative breast cancer , combination chemotherapy with multiple agents is the standard of care, especially in the case of PD-L1-positive patients, chemotherapy with an immune checkpoint inhibitor related to PD-1 (pembrolizumab or atezolizumab) is administered.
- Although the KEYNOTE355 trial demonstrated the efficacy of pembrolizumab plus paclitaxel therapy in patients with PD-L1-positive triple negative breast cancer in postoperative relapse, this trial did not include patients who received pembrolizumab in the perioperative period. Therefore, it is not known if there is any benefit to re-administering pembrolizumab to these patients after relapse.
- Bevacizumab is used as standard therapy for triple negative breast cancer in combination with paclitaxel. Bevacizumab itself is an anti-tumor agent that inhibits angiogenesis, but has also been reported to activate immunity against cancer, suggesting that it may enhance the effect of pembrolizumab.
Based on the above, the investigators planned this trial to evaluate whether pembrolizumab + paclitaxel + bevacizumab therapy is more effective than pembrolizumab + paclitaxel therapy in PD-L1-positive triple negative breast cancer patients who relapse after receiving immune checkpoint inhibitors in the perioperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + paclitaxel + bevacizumab | Experimental | Drug: Pembrolizumab, Drug: Paclitaxel, Drug: Bevacizumab |
| Pembrolizumab + paclitaxel | Active comparator | Drug: Pembrolizumab, Drug: Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male/female participants who are 18 years of age or older on the day of signing informed consent with histologically or cytologically confirmed diagnosis of invasive breast cancer will be enrolled in this study.
- Participants have been confirmed to be ER negative, HER2 negative according to the latest ASCO/CAP criteria. However, it does not matter whether the result is positive or negative for PgR.
- Participants have been confirmed to be PD-L1 positive in each site's evaluation using biopsy specimen or surgical specimen.
- Participants who have received not more than 1 prior chemotherapy regimen (including those with no prior chemotherapy) for recurrent breast cancer, excluding trial drugs of this clinical trial. (Participants with prior paclitaxel or bevacizumab for recurrent breast cancer are excluded.) However, prior treatment with Olaparib for metastatic recurrence or unresectable advanced cancer in participants with BRCA gene pathogenic variant is allowed (not counted as 1 regimen).
- Participants must have recurred after treatment with an anti-PD-1/PD-L1 antibody administered as monotherapy or in combination with other ICIs or chemotherapies as a perioperative drug therapy for triple negative breast cancer.
Key exclusion criteria (4 listed)
- Participants with progressive disease on RECIST or clinically diagnosed during preoperative ICI and chemotherapy.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years prior to enrollment.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
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 |
|---|---|---|
| PembrolizumabProtocol treatment will continue until worsening of the participant's underlying disease or unacceptable toxicity is observed or the participant withdraws the consent, or the participant meets other discontinuation criteria. Pembrolizumab: Intravenous infusion(400 mg/body, every 6 weeks starting on Day 1 of Cycle 1) | Drug | Pembrolizumab + paclitaxel, Pembrolizumab + paclitaxel + bevacizumab |
| PaclitaxelProtocol treatment will continue until worsening of the participant's underlying disease or unacceptable toxicity is observed or the participant withdraws the consent, or the participant meets other discontinuation criteria. Paclitaxel: Intravenous infusion(90 mg/m^2, on Days 1, 8, and 15, starting on Day 1 of Cycle 1 with a 28-day cycle) | Drug | Pembrolizumab + paclitaxel, Pembrolizumab + paclitaxel + bevacizumab |
| BevacizumabProtocol treatment will continue until worsening of the participant's underlying disease or unacceptable toxicity is observed or the participant withdraws the consent, or the participant meets other discontinuation criteria. Bevacizumabl: Intravenous infusion(10 mg/kg, on Days 1, and 15, starting on Day 1 of Cycle 1 with a 28-day cycle) | Drug | Pembrolizumab + paclitaxel + bevacizumab |
Primary outcome
Progression free survival
Time frame: Through protocol treatment discontinuation, approximately 9 months
4 secondary outcomes
Overall response rate
Time frame: Through protocol treatment discontinuation, approximately 9 months
Overall survival
Time frame: Through study completion, approximately 3.5 years
Disease control rate
Time frame: Through protocol treatment discontinuation, approximately 9 months
Incidence of adverse events
Time frame: Until 1 month after protocol treatment discontinuation, approximately 10 months
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 13 Jul 2026.
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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.
Toshimi Takano study chair
Cancer Institute Hospital of JFCR
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Paclitaxel and Bevacizumab in people with Recurrent Triple-Negative Breast Cancer, run by Yukinori Ozaki at 14 sites in Japan.
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 4 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Japan. 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?
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 Yukinori Ozaki (+81-3-3520-0111, yukinori.ozaki@jfcr.or.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Through protocol treatment discontinuation, approximately 9 months). 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 13 Jul 2026.