Breast CancerPhase 2NCT03430466
Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer
A Phase 2 study testing Durvalmab&Tremelimumab&Fulvestrant in people with Breast Cancer, run by Kyoto Breast Cancer Research Network at 1 site in Japan.
Trial summary
The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Durvalmab&Tremelimumab&Fulvestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteJapan
- Study dates
- 22 Jun 2017to 31 Jul 2018
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged >= 20 years at informed consent.
- Patients who have provided written informed consent themselves.
- Patients who have metastatic and/or advanced lesion
- Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells).
- Patients with cancer confirmed to be HER2-negative.
- Patients with confirmed menopause
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- Patients who have plans of 2nd hormone therapy.
- Patients with a measurable lesion based on RECIST 1.1
- Patients with ECOG PS of 0 to 1.
- Patients without any severe disorder in the major organs.
Who cannot join
- -
- Active or prior documented autoimmune disease within the past 2 years.
- Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab
- Patients with central nervous system metastasis
- Patients with life-threatening disease.
- Patients with a history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody drug.
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- Patients who have received live vaccination within 30 days before start of the investigational products.
- Patients with a past medical history of pneumonia requiring steroid treatment or with a past medical history of interstitial pneumonia.
- Patients considered ineligible for participation in this study by their attending physicians.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study to Assess Efficacy, Safety & Immunological Biomarker of Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer
The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Durvalmab&Tremelimumab&Fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalmab&Tremelimumab&FulvestrantDrug
Durvalumab and Tremelimumab once in 4 weeks Durvalumab for 13 months Tremelimumab for initial 4 months Fulvestrant : At baseline, then week 2, week 4 and after that every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Durvalmab&Tremelimumab&Fulvestrant | Experimental | Durvalmab\&Tremelimumab\&Fulvestrant Receives: Drug: Durvalmab&Tremelimumab&Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate based on RECIST1.1
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start22 Jun 2017
- Primary completion30 Jan 2018
- Study completion31 Jul 2018
Why it stopped: Recruiting was not possible
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto Breast Cancer Research Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430466
- Sponsor's protocol ID
- kbcrnb001
- Status last verified
- Aug 2020
- First submitted
- 6 Feb 2018
- Last updated
- 12 Aug 2020
- 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 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Assess Efficacy, Safety & Immunological Biomarker of Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03430466
- Acronym / sponsor ID
- kbcrnb001
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting was not possible
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Kyoto Breast Cancer Research NetworkUniversity, hospital or other
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 13 Feb 2018 (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.
The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalmab&Tremelimumab&Fulvestrant | Experimental | Drug: Durvalmab&Tremelimumab&FulvestrantDurvalmab\&Tremelimumab\&Fulvestrant |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged >= 20 years at informed consent.
- Patients who have provided written informed consent themselves.
- Patients who have metastatic and/or advanced lesion
- Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells).
- Patients with cancer confirmed to be HER2-negative.
Key exclusion criteria (9 listed)
- -
- Active or prior documented autoimmune disease within the past 2 years.
- Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab
- Patients with central nervous system metastasis
- Patients with life-threatening 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 |
|---|---|---|
| Durvalmab&Tremelimumab&FulvestrantDurvalumab and Tremelimumab once in 4 weeks Durvalumab for 13 months Tremelimumab for initial 4 months Fulvestrant : At baseline, then week 2, week 4 and after that every 4 weeks | Drug | Durvalmab&Tremelimumab&Fulvestrant |
Primary outcome
Response rate based on RECIST1.1
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Recruiting was not possible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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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 2 study testing Durvalmab&Tremelimumab&Fulvestrant in people with Breast Cancer, run by Kyoto Breast Cancer Research Network at 1 site 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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Aug 2020. 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 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?
The study was stopped early (reason given: Recruiting was not possible). 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?
Response rate based on RECIST1.1 (time frame: 2 years). 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 Aug 2020.