HR+/HER2- Advanced Breast CancerPhase 2NCT05983107
Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer
A Phase 2 study testing Everolimus, Chidamide and Endocrine therapy in people with HR+/HER2- Advanced Breast Cancer and Targeted Therapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To explore the efficacy and safety of chidamide combined with endocrine in phosphoinositide-3-kinase,catalytic,alpha gene(PI3KCA) wild type hormone receptor positive(HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer patients and to explore the efficacy and safety of Everolimus… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HR+/HER2- Advanced Breast Cancer, Targeted Therapy
- What is being tested?
- Everolimus, Chidamide and Endocrine therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2023to 15 Jul 2027
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age at the time of signing the informed consent form is ≥ 18 years old and ≤ 75 years old, for menopausal/premenopausal women (premenopausal women need to receive ovarian function suppression treatment at the same time).
- Breast cancer patients with HR positive (ER expression ≥ 10%, PR positive or negative) and HER2 negative (Immunohistochemical(IHC)0,1+; 2+, Fluorescence in situ hybridization(FISH) not expanded) confirmed by histology.
- Histologically confirmed locally advanced breast cancer (no radical local treatment) or recurrent and metastatic breast cancer.
- The patients who had previously progressed after the treatment of first-line or second-line cyclin-dependent kinases 4 and 6 inhibitors（CDK4/6 inhibitors）of endocrine and whose chemotherapy was ≤ second-line (relapse during the period of new adjuvant/adjuvant treatment or within 12 months after the end of treatment was regarded as first-line chemotherapy), the PIK3CA gene mutation detection was performed a. PIK3CA Mutant subjects were enrolled in queue A; b. PIK3CA wild-type subjects were included in queue B.
- At least one measurable primary lesion (according to RECIST v1.1 standard) before enrollment.
- The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2.
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- The toxic and side effects caused by previous anti-tumor therapy were relieved to 0-1 levels before the screening period (judged according to The NCI Common Terminology Criteria for Adverse Events version5.0 (NCICTCAE5.0); except for toxicity that researchers believe does not pose a safety risk to the subjects due to hair loss).
- The functional level of organs must meet the following requirements: 1) Blood routine:
- Absolute neutrophil count(ANC)≥1.5 × 109/L (growth factor not used within 14 days); Platelet(PLT) ≥100 × 109/L (no corrective treatment used within 7 days); Hb ≥ 100 g/L (without corrective treatment within 7 days); 2) Blood biochemistry: Total bilirubin(TBIL) ≤1.5 × upper limits of normal(ULN); Glutamine aminotransferase(ALT),Glutamic transaminase(AST)≤3 × ULN; Glutamine transpeptidase(GGT) ≤2.5 × ULN; If there is liver metastasis, then ALT and/or AST ≤ 5 × ULN; Glutamine transpeptidase GGT ≤5 × ULN; Urea, Blood urea nitrogen (BUN), creatinine (Cr) ≤1.5 × ULN; 3) Cardiac ultrasound: Left ventricular ejection fraction（LVEF）≥ 50%; 4) 12 lead ECG: QT interval (QTcF) corrected by Fridericia method, male<450ms, female.
- Expected survival time ≥ 3 months.
- Voluntarily participate in this clinical trial and sign a written informed consent form.
Who cannot join
- Those who have received any mammalian target of rapamycin（mTOR） and histone deacetylase（HDAC） inhibitors at any time in the past.
- Received chemotherapy, Targeted therapy, immunotherapy, interventional therapy or other systematic anti-tumor treatment within 4 weeks before the first administration of the study drug, or received radiotherapy within 3 weeks Note: Nitroso urea or Mitomycin C is within 6 weeks before the first use of the study drug, oral fluorouracil and small molecule targeted drugs are within 2 weeks before the first use of the study drug or within 5 half lives of the drug (whichever is longer), Traditional Chinese medicine with anti-tumor indications should be used within 2 weeks before the first use of the study drug.
- Subjects who have undergone major surgical procedures or obvious trauma within 4 weeks prior to enrollment, or are expected to undergo major surgical treatment.
- Subjects with brain or subdural metastasis are excluded. Unless its stability has been maintained for at least 4 weeks or Asymptomatic brain metastasis can be included in the group.
- According to the investigator's judgment, there are concomitant diseases (such as severe hypertension, Thyroid disease, hyperlipidemia, active infection, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study.
- Patients with poor control of diabetes shall be determined by the researcher.
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- Clinically obvious gastrointestinal abnormalities that may affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, Bowel obstruction, etc.).
- Severe cardiovascular injury (greater than a history of congestive heart failure at New York Heart Association(NYHA) level II, unstable angina or myocardial infarction within the past 6 months, or severe arrhythmia.
- Subjects have active hepatitis (hepatitis B reference: HBsAg positive and hepatitis B virus(HBV) DNA ≥ 500 international unit(IU)/ml; hepatitis C reference: hepatitis C virus(HCV) antibody positive and HCV copy number>upper limit of normal value); Subjects who are known to be positive for human immunodeficiency virus (HIV).
- Female patients during pregnancy and lactation, female patients with Fertility and positive baseline Pregnancy test, or those of childbearing age who are unwilling to take effective contraceptive measures during the whole test period and within 90 days after the last administration of the study drug.
- Have a clear history of neurological or mental disorders, including epilepsy or dementia, in the past.
- Any medical condition in which the researcher believes that the subject is not suitable for entry into the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Fei Ma, 010-87788120, drmafei@126.com
About this study
Official title: A Prospective Cohort, Open, Phase II Clinical Study of Chidamide/Everolimus Combined With Endocrine Therapy for PIK3CA Wild-type/Mutant Hormone Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer
To explore the efficacy and safety of chidamide combined with endocrine in phosphoinositide-3-kinase,catalytic,alpha gene(PI3KCA) wild type hormone receptor positive(HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer patients and to explore the efficacy and safety of Everolimus combined with endocrine therapy in patients with PI3KCA Mutant HR+/HER2- advanced breast cancer.
Read the detailed description
This study is an open, multi center, prospective cohort, and Phase II exploratory research. According to the PIK3CA gene mutation status of patients, the study is divided into two cohorts. The PIK3CA Mutant uses everolimus combined with endocrine therapy as the cohort A, and the PIK3CA wild type uses chidamide combined with endocrine therapy as the cohort B, until the disease progresses or the toxicity is intolerable. According to the judgment of the researchers, whether to enter the second stage of cross design, Queue A was cross administered with chidamide in combination with endocrine therapy. Cohort B cross used everolimus combined with endocrine until the disease progressed or the toxicity was intolerable.
- Conditions
- HR+/HER2- Advanced Breast Cancer, Targeted Therapy
- Being tested
- Everolimus, Chidamide, Endocrine therapy, Ovarian function suppression(OFS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Everolimus combined with endocrine therapy（tamoxifen, letrozole, anastrozole, exemestane, fulvestrant, etc.Goserelin, leuprolide, premenopausal patients only, selected at the discretion of the investigator）
ChidamideDrug
Chidamide combined with endocrine therapy（tamoxifen, letrozole, anastrozole, exemestane, fulvestrant, etc.goserelin, leuprolide, premenopausal patients only, selected at the discretion of the investigator）
Endocrine therapyDrug
Tamoxifen, letrozole, anastrozole, exemestane, fulvestrant, etc, selected at the discretion of the investigator.
Ovarian function suppression(OFS)Drug
Goserelin, leuprolide, premenopausal patients only, selected at the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 PIK3CA Mutant | Experimental | Everolimus combined with endocrine therapy Receives: Drug: Everolimus; Drug: Endocrine therapy; Drug: Ovarian function suppression(OFS) |
| cohort 2 PIK3CA wild type | Experimental | chidamide combined with endocrine therapy Receives: Drug: Chidamide; Drug: Endocrine therapy; Drug: Ovarian function suppression(OFS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First stage progression free survival (PFS1)
First stage progression free survival (PFS1)
Measured: 2 years
Secondary outcomes (7)
Overall survival (OS)
Overall survival (OS)
Measured: 2 years
objective response rate (ORR)
objective response rate (ORR)
Measured: 2 years
disease control rate (DCR)
disease control rate (DCR)
Measured: 2 years
clinical benefit rate (CBR)
clinical benefit rate (CBR)
Measured: 2 years
time to chemotherapy
time to chemotherapy
Measured: Through study completion，an average of 1 year
chemotherapy free survival
chemotherapy free survival
Measured: Through study completion，an average of 1 year
patient reported outcome indicators (PRO)
National Cancer Center of China-Breast Cancer-A 1.0 (NCC-BC-A 1.0) during the study was used to assess the quality of life；The minimum to maximum values: 0 , 100 Meaning: the higher scores mean a better outcome.
Measured: Through study completion，an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start20 Jul 2023
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983107
- Sponsor's protocol ID
- NCC4048
- Status last verified
- Aug 2023
- First submitted
- 18 Jul 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort, Open, Phase II Clinical Study of Chidamide/Everolimus Combined With Endocrine Therapy for PIK3CA Wild-type/Mutant Hormone Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05983107
- Acronym / sponsor ID
- NCC4048
- Conditions
- HR+/HER2- Advanced Breast Cancer, Targeted Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 9 Aug 2023 (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.
To explore the efficacy and safety of chidamide combined with endocrine in phosphoinositide-3-kinase,catalytic,alpha gene(PI3KCA) wild type hormone receptor positive(HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer patients and to explore the efficacy and safety of Everolimus combined with endocrine therapy in patients with PI3KCA Mutant HR+/HER2- advanced breast cancer.
Detailed description
This study is an open, multi center, prospective cohort, and Phase II exploratory research. According to the PIK3CA gene mutation status of patients, the study is divided into two cohorts. The PIK3CA Mutant uses everolimus combined with endocrine therapy as the cohort A, and the PIK3CA wild type uses chidamide combined with endocrine therapy as the cohort B, until the disease progresses or the toxicity is intolerable. According to the judgment of the researchers, whether to enter the second stage of cross design, Queue A was cross administered with chidamide in combination with endocrine therapy. Cohort B cross used everolimus combined with endocrine until the disease progressed or the toxicity was intolerable.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cohort 1 PIK3CA Mutant | Experimental | Drug: Everolimus, Drug: Endocrine therapy, Drug: Ovarian function suppression(OFS)Everolimus combined with endocrine therapy |
| cohort 2 PIK3CA wild type | Experimental | Drug: Chidamide, Drug: Endocrine therapy, Drug: Ovarian function suppression(OFS)chidamide combined with endocrine therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The age at the time of signing the informed consent form is ≥ 18 years old and ≤ 75 years old, for menopausal/premenopausal women (premenopausal women need to receive ovarian function suppression treatment at the same time).
- Breast cancer patients with HR positive (ER expression ≥ 10%, PR positive or negative) and HER2 negative (Immunohistochemical(IHC)0,1+; 2+, Fluorescence in situ hybridization(FISH) not expanded) confirmed by histology.
- Histologically confirmed locally advanced breast cancer (no radical local treatment) or recurrent and metastatic breast cancer.
- The patients who had previously progressed after the treatment of first-line or second-line cyclin-dependent kinases 4 and 6 inhibitors（CDK4/6 inhibitors）of endocrine and whose chemotherapy was ≤ second-line (relapse during the period of new adjuvant/adjuvant treatment or within 12 months after the end of treatment was regarded as first-line chemotherapy), the PIK3CA gene mutation detection was performed a. PIK3CA Mutant subjects were enrolled in queue A; b. PIK3CA wild-type subjects were included in queue B.
- At least one measurable primary lesion (according to RECIST v1.1 standard) before enrollment.
Key exclusion criteria (12 listed)
- Those who have received any mammalian target of rapamycin（mTOR） and histone deacetylase（HDAC） inhibitors at any time in the past.
- Received chemotherapy, Targeted therapy, immunotherapy, interventional therapy or other systematic anti-tumor treatment within 4 weeks before the first administration of the study drug, or received radiotherapy within 3 weeks Note: Nitroso urea or Mitomycin C is within 6 weeks before the first use of the study drug, oral fluorouracil and small molecule targeted drugs are within 2 weeks before the first use of the study drug or within 5 half lives of the drug (whichever is longer), Traditional Chinese medicine with anti-tumor indications should be used within 2 weeks before the first use of the study drug.
- Subjects who have undergone major surgical procedures or obvious trauma within 4 weeks prior to enrollment, or are expected to undergo major surgical treatment.
- Subjects with brain or subdural metastasis are excluded. Unless its stability has been maintained for at least 4 weeks or Asymptomatic brain metastasis can be included in the group.
- According to the investigator's judgment, there are concomitant diseases (such as severe hypertension, Thyroid disease, hyperlipidemia, active infection, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study.
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 |
|---|---|---|
| EverolimusEverolimus combined with endocrine therapy（tamoxifen, letrozole, anastrozole, exemestane, fulvestrant, etc.Goserelin, leuprolide, premenopausal patients only, selected at the discretion of the investigator） | Drug | cohort 1 PIK3CA Mutant |
| ChidamideChidamide combined with endocrine therapy（tamoxifen, letrozole, anastrozole, exemestane, fulvestrant, etc.goserelin, leuprolide, premenopausal patients only, selected at the discretion of the investigator） | Drug | cohort 2 PIK3CA wild type |
| Endocrine therapyTamoxifen, letrozole, anastrozole, exemestane, fulvestrant, etc, selected at the discretion of the investigator. | Drug | cohort 1 PIK3CA Mutant, cohort 2 PIK3CA wild type |
| Ovarian function suppression(OFS)Goserelin, leuprolide, premenopausal patients only, selected at the discretion of the investigator. | Drug | cohort 1 PIK3CA Mutant, cohort 2 PIK3CA wild type |
Primary outcome
First stage progression free survival (PFS1)
Time frame: 2 years
First stage progression free survival (PFS1)
7 secondary outcomes
Overall survival (OS)
Time frame: 2 years
objective response rate (ORR)
Time frame: 2 years
disease control rate (DCR)
Time frame: 2 years
clinical benefit rate (CBR)
Time frame: 2 years
time to chemotherapy
Time frame: Through study completion，an average of 1 year
chemotherapy free survival
Time frame: Through study completion，an average of 1 year
patient reported outcome indicators (PRO)
Time frame: Through study completion，an average of 1 year
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 9 Aug 2023.
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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.
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
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 Everolimus, Chidamide and Endocrine therapy in people with HR+/HER2- Advanced Breast Cancer and Targeted Therapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 11 inclusion and 12 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 9 Aug 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?
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?
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?
First stage progression free survival (PFS1) (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 9 Aug 2023.