Breast CancerPhase 3NCT07784036
JYP0035 Capsules Plus Fulvestrant in PIK3CA-Mutant HR+/HER2- Advanced Breast Cancer
A Phase 3 study testing JYP0035 plus Fulvestrant in people with Breast Cancer, run by Chengdu JOYO pharma Co., Ltd..
Trial summary
This is a Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of JYP0035 Capsules in Combination With Fulvestrant in Patients With PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Progressed on Prior Endocrine Therapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- JYP0035 plus Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Jun 2029
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the clinical study and provide written informed consent (ICF).
- Aged 18 to 75 years (inclusive) at the time of signing the main ICF, of any sex.
- Histologically and/or cytologically confirmed locally advanced breast cancer (LABC) not amenable to curative surgery or metastatic breast cancer (mBC), with pathology confirming hormone receptor (HR)-positive and HER2-negative disease (based on the most recent test result); per the 2020 ASCO/CAP guidelines, HR-positive is defined as ER-positive and/or PR-positive with ≥1% of tumor cells showing positive staining, and HER2-negative is defined as IHC 0 or 1+, or IHC 2+ with negative ISH.
- Must provide a fresh or archived FFPE tumor tissue block or unstained slides for central laboratory confirmation of PIK3CA mutation status and site.
- Postmenopausal women, as well as premenopausal/perimenopausal women, are eligible; male participants and premenopausal/perimenopausal women - - must receive ovarian suppression (e.g., continuous LHRH agonist such as goserelin or leuprorelin) during the study; postmenopausal status in women is defined per NCCN Breast Cancer Guidelines 2026 V2 as age ≥60 years, or age <60 years with amenorrhea ≥12 months and postmenopausal FSH/estradiol levels (without prior chemotherapy/endocrine therapy/suppression) or chemotherapy-induced amenorrhea ≥12 months with postmenopausal FSH/estradiol, or on tamoxifen with postmenopausal FSH/estradiol, or prior bilateral oophorectomy.
- Prior at least one line of endocrine therapy (monotherapy or combination including AI or SERM) with failure: relapse/progression during (neo)adjuvant endocrine therapy or within 12 months after adjuvant completion counted as first-line, or progression on endocrine therapy in LABC/mBC setting; in LABC/mBC, prior systemic therapy must be endocrine ≤2 lines and chemotherapy ≤1 line; note at least 80% of participants must have received prior CDK4/6 inhibitor.
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- At least one measurable lesion per RECIST v1.1, or at least one osteolytic or mixed osteolytic-osteosclerotic bone lesion; sclerotic/osteoblastic-only bone lesions without measurable disease are not eligible; previously locally treated lesions may be target lesions only if documented radiologic progression occurred.
- ECOG performance status 0-1.
- Expected survival ≥6 months.
- Adequate organ function before first dose (no blood products/cytokines/EPO within 14 days, no oral leukocyte boosters within 7 days): ANC >1.5×10⁹/L, platelets >100×10⁹/L, hemoglobin >90 g/L, serum creatinine <1.5×ULN or CrCl >50 mL/min (Cockcroft-Gault) if ≥1.5×ULN, total bilirubin <1.5×ULN, AST/ALT <2.5×ULN (<5×ULN with liver mets), APTT and INR <1.5×ULN, FPG <7.0 mmol/L, HbA1c <6.5%.
- Females of childbearing potential must have negative serum pregnancy test within 7 days before first dose; all fertile participants (male and female) must agree to reliable contraception (abstinence, barrier, hormonal, IUD, sterilization, etc.) during treatment and 90 days after last dose.
- Assessed by investigator as suitable for fulvestrant treatment without contraindications.
Who cannot join
- Presence of PTEN loss or concurrent AKT1 E17K mutation. Prior use of fulvestrant, other selective estrogen receptor degraders (SERDs), or any PI3K/AKT/mTOR inhibitor.
- Receipt of any anticancer therapy (including investigational anticancer drugs) within 4 weeks before first study drug administration, with the following exceptions:
- Nitrosoureas or mitomycin C within 6 weeks before first dose (due to delayed toxicity);
- Anticancer endocrine therapy, oral fluoropyrimidines, or small-molecule targeted drugs within 2 weeks or 5 half-lives (whichever is shorter) before first dose;
- Anticancer traditional Chinese medicine/herbal formulations within 2 weeks before first dose;
- Palliative local radiotherapy (e.g., thoracic spine or rib radiotherapy) within 2 weeks before first dose.
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- Failure to recover from any prior anticancer-treatment-related adverse event or complication to baseline or ≤Grade 1, except toxicities judged by the investigator as having no safety risk (e.g., alopecia, hyperpigmentation, Grade 2 peripheral neuropathy, hypothyroidism stable on hormone replacement).
- Known active central nervous system (CNS) metastasis (note: previously treated brain metastases are allowed if radiologically stable [no progression for ≥4 weeks on imaging performed during screening], clinically stable, and no steroid requirement for ≥14 days before planned start; any leptomeningeal metastasis/carcinomatous meningitis is excluded).
- Major surgical procedure within 4 weeks before first dose (excluding biopsy, venous access, ureteral stent, etc.), significant trauma, or anticipated major surgery during the study; minor traumatic surgery (biopsy, endoscopy, drainage) within 7 days before first dose.
- History of another malignancy within 3 years before first dose (except cured basal cell or squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of breast, papillary thyroid carcinoma).
- Gastrointestinal disease affecting drug administration/absorption, including but not limited to bowel obstruction, dysphagia/inability to swallow tablets, refractory nausea/vomiting/diarrhea, chronic GI diseases (Crohn's disease, ulcerative colitis).
- Severe cardiovascular or cerebrovascular disease, including but not limited to:
- Serious cardiac rhythm or conduction abnormality requiring intervention (e.g., ventricular/supraventricular arrhythmia, II-III degree AV block, QTcF ≥470 ms in males or ≥480 ms in females [QTcF = QT/RR^0.33; if abnormal at screening, repeat 3 times 2-5 min apart and take mean]); b) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other ≥Grade 3 cardio/cerebrovascular event within 6 months before first dose; c) NYHA functional class ≥II, congestive heart failure, or LVEF <50%; d) Any factor increasing QTc prolongation or arrhythmic risk (e.g., heart failure, hypokalemia, congenital long QT syndrome, family history of long QT, known QT-prolonging concomitant drugs); e) Uncontrolled hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg on regular antihypertensives), or history of hypertensive crisis/encephalopathy; f) Arteriovenous thrombosis, pulmonary embolism, or other severe thrombotic event within 6 months before first dose (port catheter or catheter-related thrombosis, superficial venous thrombosis not considered "severe").
- History of type 1 diabetes, type 2 diabetes, or gestational diabetes.
- History of moderate-to-severe pulmonary disease significantly affecting respiratory function or interfering with drug-related pulmonary toxicity assessment/management, including COPD, interstitial lung disease/pneumonitis, radiation pneumonitis, idiopathic pulmonary fibrosis, pulmonary embolism, severe asthma, severe obstructive/restrictive ventilatory defect, any autoimmune/connective tissue/inflammatory disease with pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's, sarcoidosis), prior pneumonectomy; active pulmonary inflammation or interstitial lung disease on screening chest imaging; active tuberculosis or active TB infection within 1 year before first dose regardless of treatment.
- Systemic corticosteroid or immunosuppressant therapy within 14 days before first dose that cannot be discontinued, except: low-dose prednisone ≤10 mg/day (or equivalent), local/ocular/intra-articular/nasal/inhaled corticosteroids, short-term corticosteroids for prophylaxis/treatment (e.g., allergy prevention, edema control).
- Serious systemic active infection within 4 weeks before first dose, or unexplained fever ≥38.5°C with IV antimicrobial requirement within 2 weeks before first dose; prophylactic antibiotics (e.g., for urinary tract infection) allowed.
- Judged by investigator as unsuitable for endocrine anticancer therapy (e.g., inflammatory breast cancer, symptomatic visceral crisis threatening life in short term such as uncontrolled/recurrent pleural/pericardial/ascitic effusion requiring drainage).
- History of Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), or severe skin disease (≥Grade 3).
- HIV antibody positive; active hepatitis B (HBsAg positive and HBV DNA >2000 IU/mL or >10^4 copies/mL); active hepatitis C (HCV antibody positive with detectable HCV RNA); co-infection of HBV and HCV (HBsAg positive and HCV antibody positive); active syphilis (if specific antibody positive and non-specific antibody [RPR/TRUST] positive with titer <1:2 and clinically confirmed inactive, may be screened).
- Allergy or contraindication to any active or inactive component of study drugs (JYP0035 or fulvestrant) and LHRH agonist (only for those requiring LHRH agonist co-therapy).
- Pregnant (or planning pregnancy) or lactating females. History of immunodeficiency including congenital or acquired immunodeficiency, prior organ transplantation, or awaiting organ transplantation.
- In the investigator's judgment, other factors that may affect study results or force premature termination (e.g., alcoholism, drug abuse, other severe diseases including psychiatric or significant CNS abnormalities requiring concomitant treatment, markedly abnormal labs, uncontrolled metabolic disorder, uncontrolled diabetes/hyperglycemia, chronic kidney disease, familial/social factors impairing safety/compliance/data collection).
About this study
Official title: A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of JYP0035 Capsules in Combination With Fulvestrant in Patients With PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Progressed on Prior Endocrine Therapy
This is a Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of JYP0035 Capsules in Combination With Fulvestrant in Patients With PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Progressed on Prior Endocrine Therapy
- Conditions
- Breast Cancer
- Being tested
- JYP0035 plus Fulvestrant, JYP0035 placebo plus 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.
JYP0035 plus FulvestrantDrug
JYP0035 capsules 100 mg administered orally twice daily (BID). Fulvestrant 500 mg administered intramuscularly on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then on Day 1 of each subsequent 28-day cycle. One cycle is defined as 4 weeks (28 days).
JYP0035 placebo plus FulvestrantDrug
JYP0035 placebo 100 mg administered orally twice daily (BID). Fulvestrant 500 mg administered intramuscularly on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then on Day 1 of each subsequent 28-day cycle. One cycle is defined as 4 weeks (28 days).
| Study group | Role | What they receive |
|---|---|---|
| JYP0035 plus Fulvestrant | Experimental | Not described Receives: Drug: JYP0035 plus Fulvestrant |
| Placebo plus Fulvestrant | Active comparator | Not described Receives: Drug: JYP0035 placebo plus Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Tumor imaging assessments will be performed every 8 weeks (±7 days) starting from Cycle 1 Day 1 (C1D1), and every 12 weeks (±7 days) after Week 48, until radiologic disease progression, initiation of new anti-cancer t(e.g., up to approximately 24 months)
Secondary outcomes (3)
Investigator-assessed PFS (RECIST v1.1)
PFS determined by the investigator per RECIST v1.1, defined as time from randomization to first documented disease progression or death from any cause, whichever occurs first.
Measured: up to approximately 24 months
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: Every 8 weeks after discontinuation of study treatment until death or loss to follow-up (e.g., up to approximately 60 months)
Objective Response Rate (ORR) by BICR / by Investigator
ORR defined as percentage of subjects with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. BICR and investigator assessments performed independently.
Measured: up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Jun 2029 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu JOYO pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784036
- Sponsor's protocol ID
- JYP0035M301
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of JYP0035 Capsules in Combination With Fulvestrant in Patients With PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Progressed on Prior Endocrine Therapy
- ClinicalTrials.gov ID
- NCT07784036
- Acronym / sponsor ID
- JYP0035M301
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- Chengdu JOYO pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 25 Aug 2026 (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 is a Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of JYP0035 Capsules in Combination With Fulvestrant in Patients With PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Progressed on Prior Endocrine Therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JYP0035 plus Fulvestrant | Experimental | Drug: JYP0035 plus Fulvestrant |
| Placebo plus Fulvestrant | Active comparator | Drug: JYP0035 placebo plus Fulvestrant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily participate in the clinical study and provide written informed consent (ICF).
- Aged 18 to 75 years (inclusive) at the time of signing the main ICF, of any sex.
- Histologically and/or cytologically confirmed locally advanced breast cancer (LABC) not amenable to curative surgery or metastatic breast cancer (mBC), with pathology confirming hormone receptor (HR)-positive and HER2-negative disease (based on the most recent test result); per the 2020 ASCO/CAP guidelines, HR-positive is defined as ER-positive and/or PR-positive with ≥1% of tumor cells showing positive staining, and HER2-negative is defined as IHC 0 or 1+, or IHC 2+ with negative ISH.
- Must provide a fresh or archived FFPE tumor tissue block or unstained slides for central laboratory confirmation of PIK3CA mutation status and site.
- Postmenopausal women, as well as premenopausal/perimenopausal women, are eligible; male participants and premenopausal/perimenopausal women - - must receive ovarian suppression (e.g., continuous LHRH agonist such as goserelin or leuprorelin) during the study; postmenopausal status in women is defined per NCCN Breast Cancer Guidelines 2026 V2 as age ≥60 years, or age <60 years with amenorrhea ≥12 months and postmenopausal FSH/estradiol levels (without prior chemotherapy/endocrine therapy/suppression) or chemotherapy-induced amenorrhea ≥12 months with postmenopausal FSH/estradiol, or on tamoxifen with postmenopausal FSH/estradiol, or prior bilateral oophorectomy.
Key exclusion criteria (23 listed)
- Presence of PTEN loss or concurrent AKT1 E17K mutation. Prior use of fulvestrant, other selective estrogen receptor degraders (SERDs), or any PI3K/AKT/mTOR inhibitor.
- Receipt of any anticancer therapy (including investigational anticancer drugs) within 4 weeks before first study drug administration, with the following exceptions:
- Nitrosoureas or mitomycin C within 6 weeks before first dose (due to delayed toxicity);
- Anticancer endocrine therapy, oral fluoropyrimidines, or small-molecule targeted drugs within 2 weeks or 5 half-lives (whichever is shorter) before first dose;
- Anticancer traditional Chinese medicine/herbal formulations within 2 weeks before first dose;
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 |
|---|---|---|
| JYP0035 plus FulvestrantJYP0035 capsules 100 mg administered orally twice daily (BID). Fulvestrant 500 mg administered intramuscularly on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then on Day 1 of each subsequent 28-day cycle. One cycle is defined as 4 weeks (28 days). | Drug | JYP0035 plus Fulvestrant |
| JYP0035 placebo plus FulvestrantJYP0035 placebo 100 mg administered orally twice daily (BID). Fulvestrant 500 mg administered intramuscularly on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then on Day 1 of each subsequent 28-day cycle. One cycle is defined as 4 weeks (28 days). | Drug | Placebo plus Fulvestrant |
Primary outcome
Progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Tumor imaging assessments will be performed every 8 weeks (±7 days) starting from Cycle 1 Day 1 (C1D1), and every 12 weeks (±7 days) after Week 48, until radiologic disease progression, initiation of new anti-cancer t(e.g., up to approximately 24 months)
3 secondary outcomes
Investigator-assessed PFS (RECIST v1.1)
Time frame: up to approximately 24 months
Overall Survival (OS)
Time frame: Every 8 weeks after discontinuation of study treatment until death or loss to follow-up (e.g., up to approximately 60 months)
Objective Response Rate (ORR) by BICR / by Investigator
Time frame: up to approximately 24 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 25 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JYP0035 plus Fulvestrant in people with Breast Cancer, run by Chengdu JOYO pharma Co., Ltd..
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 12 inclusion and 23 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: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (time frame: Tumor imaging assessments will be performed every 8 weeks (±7 days) starting from Cycle 1 Day 1 (C1D1), and every 12 weeks (±7 days) after Week 48, until radiologic disease progression, initiation of new anti-cancer t(e.g., up to approximately 24 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 25 Aug 2026.