Breast CancerPhase 2NCT05205200
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
A Phase 2 study testing SHR-1316, SHR6390 and Nab paclitaxel in people with Breast Cancer and Metastatic Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Metastatic Cancer
- What is being tested?
- SHR-1316, SHR6390 and Nab paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2022to 1 Aug 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females ≥18 years and ≤ 75 years old;
- Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER> 10% tumor cell positive is defined as ER positive, PR> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative);
- Subtype of similarity network fusion-2 (SNF-2) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital
- Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer;
- Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions;
- Has adequate bone marrow function: absolute neutrophil count > 1.5x10ˆ9 /L; platelet count > 75x10ˆ9 /L, hemoglobin > 9g/dL;
Show all 10Show fewer
- Patients had received no previous chemotherapy or targeted therapy for metastatic disease
- Has adequate liver function and kidney function: serum creatinine
- ECOG score ≤ 2 and life expectancy ≥ 3 months;
- Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.
Who cannot join
- Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease
- Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms);
- Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months);
- is pregnant or breast feeding;
- Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
- History of autoimmune disease
Show all 10Show fewer
- Positive test for human immunodeficiency virus
- Active hepatitis B or hepatitis C
- Uncontrolled pleural effusion and ascites
- Thyroid dysfunction.
Trial locations and contacts
1 site in 1 country.
Zhong-Hua Wang contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai cancer center
Shanghai, 200032
Min U He, M.D., 021-64175590 ext. 88603, minsmiler@126.com
About this study
Official title: Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Read the detailed description
Patients with SNF2 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. Five treatment arms were set up based on the whether they have exposed to CDK4/6 inhibitors before. The main purpose is to evaluate immune therapy in SNF2 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.
- Conditions
- Breast Cancer, Metastatic Cancer
- Being tested
- SHR-1316, SHR6390, Nab paclitaxel, SERD, AI
- Keywords
- first-line therapy
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1316Drug
PD-L1 antibody
SHR6390Drug
CDK4/6 inhibitor
Nab paclitaxelDrug
Albumin bound paclitaxel
SERDDrug
Fulvestrant
AIDrug
aromatase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A | Experimental | In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1316 (anti-PD-L1) and endocrine therapy. Receives: Drug: SHR-1316; Drug: SHR6390; Drug: SERD; Drug: AI |
| Cohort 1B | Active comparator | In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with endocrine therapy. Receives: Drug: SHR6390; Drug: SERD; Drug: AI |
| Cohort 2A | Experimental | In this cohort, a patient would receive SHR1316 (anti-PD-L1) combined with nab-paclitaxel. Receives: Drug: SHR-1316; Drug: Nab paclitaxel |
| Cohort 2B | Active comparator | In this cohort, a patient would single nab-paclitaxel. Receives: Drug: Nab paclitaxel |
| Cohort 2C | Other | In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with fulvestrant. Receives: Drug: SHR-1316; Drug: SERD |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
time to progressive disease (according to RECIST1.1)
Measured: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
Secondary outcomes (3)
ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Measured: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
CBR
the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the
Measured: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
OS
time to death due to any cause
Measured: Randomization to death from any cause, through the end of study (approximately 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start6 Jun 2022
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
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.
- More trials run by Fudan UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, First Hospital of China Medical University, Sun Yat-sen University, First Affiliated Hospital Xi'an Jiaotong University, Liaoning Cancer Hospital & Institute, Chongqing University Cancer Hospital, Northern Jiangsu People's Hospital, Fujian Medical University Union Hospital, Ningbo Medical Center Lihuili Hospital, Shanghai First Maternity and Infant Hospital, Shanghai 6th People's Hospital, Affiliated Hospital of Nantong University
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhi-Ming Shao, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205200
- Sponsor's protocol ID
- FUSCC
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2022
- Last updated
- 8 Feb 2024
- 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 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05205200
- Acronym / sponsor ID
- FUSCC
- Conditions
- Breast Cancer, Metastatic Cancer
- Keywords
- first-line therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, First Hospital of China Medical University, Sun Yat-sen University, First Affiliated Hospital Xi'an Jiaotong University, Liaoning Cancer Hospital & Institute, Chongqing University Cancer Hospital, Northern Jiangsu People's Hospital, Fujian Medical University Union Hospital, Ningbo Medical Center Lihuili Hospital, Shanghai First Maternity and Infant Hospital, Shanghai 6th People's Hospital, Affiliated Hospital of Nantong University
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 25 Jan 2022 (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 prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Detailed description
Patients with SNF2 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. Five treatment arms were set up based on the whether they have exposed to CDK4/6 inhibitors before. The main purpose is to evaluate immune therapy in SNF2 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A | Experimental | Drug: SHR-1316, Drug: SHR6390, Drug: SERD, Drug: AIIn this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1316 (anti-PD-L1) and endocrine therapy. |
| Cohort 1B | Active comparator | Drug: SHR6390, Drug: SERD, Drug: AIIn this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with endocrine therapy. |
| Cohort 2A | Experimental | Drug: SHR-1316, Drug: Nab paclitaxelIn this cohort, a patient would receive SHR1316 (anti-PD-L1) combined with nab-paclitaxel. |
| Cohort 2B | Active comparator | Drug: Nab paclitaxelIn this cohort, a patient would single nab-paclitaxel. |
| Cohort 2C | Other | Drug: SHR-1316, Drug: SERDIn this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with fulvestrant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Females ≥18 years and ≤ 75 years old;
- Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER> 10% tumor cell positive is defined as ER positive, PR> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative);
- Subtype of similarity network fusion-2 (SNF-2) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital
- Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer;
- Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions;
Key exclusion criteria (10 listed)
- Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic 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 |
|---|---|---|
| SHR-1316PD-L1 antibody | Drug | Cohort 1A, Cohort 2A, Cohort 2C |
| SHR6390CDK4/6 inhibitor | Drug | Cohort 1A, Cohort 1B |
| Nab paclitaxelAlbumin bound paclitaxel | Drug | Cohort 2A, Cohort 2B |
| SERDFulvestrant | Drug | Cohort 1A, Cohort 1B, Cohort 2C |
| AIaromatase inhibitor | Drug | Cohort 1A, Cohort 1B |
Primary outcome
PFS
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
time to progressive disease (according to RECIST1.1)
3 secondary outcomes
ORR
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
CBR
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
OS
Time frame: Randomization to death from any cause, through the end of study (approximately 5 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Zhong-Hua Wang contact
Zhi-Ming Shao principal investigator
Fudan University
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 SHR-1316, SHR6390 and Nab paclitaxel in people with Breast Cancer and Metastatic 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 10 inclusion and 10 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 8 Feb 2024. 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?
Contact Zhi-Ming Shao (86-021-64175590 ext. 8888, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 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 8 Feb 2024.