Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients
NCT ID: NCT06635447
Last Updated: 2026-01-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
300 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-09-26
Study Completion Date
2027-01-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is a multi-center, two-cohorts, phase IIIb study of Capivasertib+Fulvestrant in HR+/HER2-ABC who had disease recurrence/progression following 1-2L endocrine therapy.
The Primary objective is to assess the efficacy of capi+ful by assessment of TFST (Time to first subsequent treatment) of PIK3CA/AKT1/PTEN-altered subgroup in cohort1.
The Primary objective is to assess the efficacy of capi+ful by assessment of TFST (Time to first subsequent treatment) of PIK3CA/AKT1/PTEN-altered subgroup in cohort1.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer
NCT04305496
Locally Advanced (Inoperable) or Metastatic Breast Cancer
ACTIVE_NOT_RECRUITING
PHASE3
Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer
NCT04263298
Metastatic Breast Cancer
RECRUITING
PHASE3
Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
NCT06851442
Breast Cancer
TERMINATED
PHASE1/PHASE2
Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer
NCT04646759
Breast Cancer
RECRUITING
PHASE3
PARP Inhibitor With CDK4/ 6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
NCT06612814
Breast Cancer Metastatic
ACTIVE_NOT_RECRUITING
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will enroll about 300 patients in 2 cohorts . Cohort1 will include patients without prior fulvestrant treated and Cohort2 will include patients who received fulvestrant as the first-line treatment and progression ≥6 months after the first dosing of fulvestrant. Approximately 195 patients will be enrolled in Cohort1 and 105 patients will be enrolled in Cohort2.
All patients will receive weekly capivasertib (400 mg, oral, twice daily; 4 days on and 3 days off) and fulvestrant (at the approved dose regimen \[500 mg intramuscular injections on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter\]). All patients will attend a screening visit a maximum of 28 days prior to the start of study treatment.
All patients will receive weekly capivasertib (400 mg, oral, twice daily; 4 days on and 3 days off) and fulvestrant (at the approved dose regimen \[500 mg intramuscular injections on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter\]). All patients will attend a screening visit a maximum of 28 days prior to the start of study treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Breast Cancer
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
Capivasertib+Fulvestrant
Group Type
EXPERIMENTAL
Capivasertib
Intervention Type
DRUG
400 mg, oral, twice daily; 4 days on and 3 days off
Fulvestrant
Intervention Type
DRUG
Fulvestrant IV
Cohort 2
Capivasertib+Fulvestrant
Group Type
EXPERIMENTAL
Capivasertib
Intervention Type
DRUG
400 mg, oral, twice daily; 4 days on and 3 days off
Fulvestrant
Intervention Type
DRUG
Fulvestrant IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Capivasertib
400 mg, oral, twice daily; 4 days on and 3 days off
Intervention Type
DRUG
Fulvestrant
Fulvestrant IV
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
AZD5363
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the clinical study protocol (CSP).
2. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.
3. Patients must be aged ≥18 years at the time of signing the ICF
4. Adult females, pre- and/or post-menopausal, and adult males -Pre-menopausal (and peri-menopausal i.e., those that do not meet the criteria for post-menopausal defined below) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study -Post-menopausal women are defined as: a)aged ≥60 years of age, or b)aged \<60 years of age and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments/chemotherapy/ovarian suppression/tamoxifen or similar. These patients should also have serum oestradiol and follicle stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for post-menopausal females, or c)documented bilateral oophorectomy
5. Histologically confirmed HR+/HER2- breast cancer determined from the most recent tumour sample (primary or metastatic), as per the American Society of Clinical Oncology and College of American Pathologists guideline recommendations. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor. 1)ER+ defined as ≥1% of tumour cells stain positive for ER on immunohistochemistry (IHC) or, if no percentage is available, then an Allred IHC score of ≥3/8, 2)Progesterone receptor positive defined as ≥1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≥3/8; or progesterone receptor negative defined as \<1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≤2/8; or progesterone receptor unknown, 3)or the investigator assesses the condition as HR+ status and 4)HER2- defined as 0 or 1+ intensity on IHC, or 2+ intensity on IHC and no evidence of amplification on in situ hybridisation (ISH), or if IHC not done, no evidence of amplification on ISH.
Metastatic or locally advanced disease with radiographic or objective evidence of recurrence or progression (cancer that has progressed during or after a recent treatment period).; locally advanced disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible) Patients are to have received treatment with an endocrine therapy containing regimen (single agent or in combination) and have: a)Radiological evidence of breast cancer recurrence or progression during treatment or within 12 months after the end of treatment with a neoadjuvant or adjuvant endocrine therapy, OR b)Radiological evidence of progression while on prior ET administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy) (for patients with breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an ET will be limited to approximately 10%).
6. Patients must have at least 1 measurable lesion.
7. Patients must be eligible for fulvestrant therapy as per local investigator assessment.
8. Consent to submit and provide a mandatory FFPE tumour sample for central testing.
9. Patients must be able to swallow and retain oral medication.
10. Eastern Cooperative Oncology Group (ECOG)/ World Health Organisation (WHO) performance status 0 or 1 and life expectancy of ≥12 weeks.
11. Patients with PIK3CA/AKT1/PTEN alterations confirmed by central laboratory NGS testing. (Note: Applicable exclusively to patients enrolled under Protocol Version 2.0.)
13. Known active hepatitis B or C infection, positive hepatitis C antibody, positive hepatitis B virus surface antigen. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients receiving antiretroviral therapies which are strong inhibitors or inducers of CYP3A4 will be excluded due to the potential for drug-drug interaction with capivasertib as per Table 19 Drug Interactions that affect Capivasertib.
14. Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or LHRH agonist (if applicable)
15. Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib
16. Previous allogenic bone marrow or solid organ transplant
17. Known immunodeficiency syndrome
18. History of hypersensitivity to active or inactive excipients of capivasertib, fulvestrant and LHRH agonists (if applicable, i.e., concomitant LHRH agonist required in this study) or drugs with a similar chemical structure or class to capivasertib, fulvestrant or LHRH agonists (if applicable, i.e., concomitant LHRH agonist required in this study)
19. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
21. More than 2 lines of endocrine therapy for inoperable locally advanced or metastatic disease in Cohort 1; More than 1 lines endocrine therapy for inoperable locally advanced or metastatic disease in Cohort2 For Cohort 2, Patients must receive fulvestrant ≤ 1L endocrine treatment for ABC and progression \<6 months after the first dosing of fulvestrant.
For patients with breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an ET will be limited to approximately 10%.
NOTE: If an attempt to downstage a locally advanced tumour with endocrine therapy was made in the absence of metastatic breast cancer (neoadjuvant), and the tumour operated upon, then this does not count as a line of therapy for ABC. In contrast, if the tumour remained inoperable, this treatment should be included as a line of therapy for ABC. Adjuvant endocrine therapy is not considered a line of therapy for ABC. In addition, switching drugs within a line of therapy to manage toxicities in the absence of progressive disease does NOT count as a new line of therapy.
22. More than 1 line of chemotherapy for inoperable locally advanced or metastatic disease (Patients experienced recurrence or progression during chemotherapy of ABC will be limited to a maximum approximately of 15% of the total study population; once this limit is met the enrolment of this group of patients should be terminated). Adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for ABC
23. Prior treatment with any of the following: a)AKT, PI3K and mTOR inhibitors b)Fulvestrant, and other SERDs in Cohort1 c)Nitrosourea or mitomycin C within 6 weeks prior to study treatment initiation d)Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation. A longer washout period may be required for drugs with a long half-life (e.g., biologics) as agreed by the sponsor e)Systemic therapy: Prior exposure to any chemotherapy or anti-cancer agents other than those specified in the protocol (e.g. hormonal therapy such as LHRH agonists) without appropriate washout period before enrolment, for example, enrolment within 3 half-lives of a small molecule anti-cancer agent, or within 4 weeks for any antibody-based anticancer agents. f)Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort) or drugs that are sensitive to CYP3A4 inhibition within 1 week prior to study treatment initiation. g)Any concomitant medication that may interfere with fulvestrant safety and efficacy based on the prescribing information of fulvestrant and local clinical guidelines.
24. Participation in another clinical study with a non-marketed investigational medicinal product (IMP) administered in the last 30 days or 5 half-lives, whichever is longer (for IMPs which are a previously marketed drug, regardless of indication.)
25. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
26. Pregnant women (confirmed with positive pregnancy test) or breast-feeding women or women who are planning to become pregnant.
2. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.
3. Patients must be aged ≥18 years at the time of signing the ICF
4. Adult females, pre- and/or post-menopausal, and adult males -Pre-menopausal (and peri-menopausal i.e., those that do not meet the criteria for post-menopausal defined below) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study -Post-menopausal women are defined as: a)aged ≥60 years of age, or b)aged \<60 years of age and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments/chemotherapy/ovarian suppression/tamoxifen or similar. These patients should also have serum oestradiol and follicle stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for post-menopausal females, or c)documented bilateral oophorectomy
5. Histologically confirmed HR+/HER2- breast cancer determined from the most recent tumour sample (primary or metastatic), as per the American Society of Clinical Oncology and College of American Pathologists guideline recommendations. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor. 1)ER+ defined as ≥1% of tumour cells stain positive for ER on immunohistochemistry (IHC) or, if no percentage is available, then an Allred IHC score of ≥3/8, 2)Progesterone receptor positive defined as ≥1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≥3/8; or progesterone receptor negative defined as \<1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≤2/8; or progesterone receptor unknown, 3)or the investigator assesses the condition as HR+ status and 4)HER2- defined as 0 or 1+ intensity on IHC, or 2+ intensity on IHC and no evidence of amplification on in situ hybridisation (ISH), or if IHC not done, no evidence of amplification on ISH.
Metastatic or locally advanced disease with radiographic or objective evidence of recurrence or progression (cancer that has progressed during or after a recent treatment period).; locally advanced disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible) Patients are to have received treatment with an endocrine therapy containing regimen (single agent or in combination) and have: a)Radiological evidence of breast cancer recurrence or progression during treatment or within 12 months after the end of treatment with a neoadjuvant or adjuvant endocrine therapy, OR b)Radiological evidence of progression while on prior ET administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy) (for patients with breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an ET will be limited to approximately 10%).
6. Patients must have at least 1 measurable lesion.
7. Patients must be eligible for fulvestrant therapy as per local investigator assessment.
8. Consent to submit and provide a mandatory FFPE tumour sample for central testing.
9. Patients must be able to swallow and retain oral medication.
10. Eastern Cooperative Oncology Group (ECOG)/ World Health Organisation (WHO) performance status 0 or 1 and life expectancy of ≥12 weeks.
11. Patients with PIK3CA/AKT1/PTEN alterations confirmed by central laboratory NGS testing. (Note: Applicable exclusively to patients enrolled under Protocol Version 2.0.)
13. Known active hepatitis B or C infection, positive hepatitis C antibody, positive hepatitis B virus surface antigen. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients receiving antiretroviral therapies which are strong inhibitors or inducers of CYP3A4 will be excluded due to the potential for drug-drug interaction with capivasertib as per Table 19 Drug Interactions that affect Capivasertib.
14. Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or LHRH agonist (if applicable)
15. Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib
16. Previous allogenic bone marrow or solid organ transplant
17. Known immunodeficiency syndrome
18. History of hypersensitivity to active or inactive excipients of capivasertib, fulvestrant and LHRH agonists (if applicable, i.e., concomitant LHRH agonist required in this study) or drugs with a similar chemical structure or class to capivasertib, fulvestrant or LHRH agonists (if applicable, i.e., concomitant LHRH agonist required in this study)
19. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
21. More than 2 lines of endocrine therapy for inoperable locally advanced or metastatic disease in Cohort 1; More than 1 lines endocrine therapy for inoperable locally advanced or metastatic disease in Cohort2 For Cohort 2, Patients must receive fulvestrant ≤ 1L endocrine treatment for ABC and progression \<6 months after the first dosing of fulvestrant.
For patients with breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an ET will be limited to approximately 10%.
NOTE: If an attempt to downstage a locally advanced tumour with endocrine therapy was made in the absence of metastatic breast cancer (neoadjuvant), and the tumour operated upon, then this does not count as a line of therapy for ABC. In contrast, if the tumour remained inoperable, this treatment should be included as a line of therapy for ABC. Adjuvant endocrine therapy is not considered a line of therapy for ABC. In addition, switching drugs within a line of therapy to manage toxicities in the absence of progressive disease does NOT count as a new line of therapy.
22. More than 1 line of chemotherapy for inoperable locally advanced or metastatic disease (Patients experienced recurrence or progression during chemotherapy of ABC will be limited to a maximum approximately of 15% of the total study population; once this limit is met the enrolment of this group of patients should be terminated). Adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for ABC
23. Prior treatment with any of the following: a)AKT, PI3K and mTOR inhibitors b)Fulvestrant, and other SERDs in Cohort1 c)Nitrosourea or mitomycin C within 6 weeks prior to study treatment initiation d)Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation. A longer washout period may be required for drugs with a long half-life (e.g., biologics) as agreed by the sponsor e)Systemic therapy: Prior exposure to any chemotherapy or anti-cancer agents other than those specified in the protocol (e.g. hormonal therapy such as LHRH agonists) without appropriate washout period before enrolment, for example, enrolment within 3 half-lives of a small molecule anti-cancer agent, or within 4 weeks for any antibody-based anticancer agents. f)Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort) or drugs that are sensitive to CYP3A4 inhibition within 1 week prior to study treatment initiation. g)Any concomitant medication that may interfere with fulvestrant safety and efficacy based on the prescribing information of fulvestrant and local clinical guidelines.
24. Participation in another clinical study with a non-marketed investigational medicinal product (IMP) administered in the last 30 days or 5 half-lives, whichever is longer (for IMPs which are a previously marketed drug, regardless of indication.)
25. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
26. Pregnant women (confirmed with positive pregnancy test) or breast-feeding women or women who are planning to become pregnant.
Exclusion Criteria
1. A disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgement (e.g., symptomatic visceral disease that is potentially life-threatening in the short-term)
2. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease. Radiotherapy within 2 weeks prior to the first dose of study intervention. Major surgery (excluding placement of vascular access) within 4 weeks prior to study treatment initiation
3. With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
4. Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation
5. Leptomeningeal metastase
6. Active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
7. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
8. Any of the following cardiac criteria: a)Mean resting QT interval corrected by Fridericia's formula (QTcF) \>470 msec obtained from 3 consecutive ECGs b)History of QT prolongation associated with other medications that required discontinuation of that medication. - Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block) c)Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study based on the Investigator judgement with cardiologist consultation recommended. d)Any factors that increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, clinically significant electrolyte abnormalities including hypokalaemia, hypomagnesaemia, and hypocalcaemia, potential for Torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval e)Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, myocardial infarction, unstable angina pectoris, f)Congestive heart failure New York Heart Association (NYHA) grade ≥2
9. Clinically significant abnormalities of glucose metabolism defined as HbA1c ≥8.0% (63.9 mmol/mol) at screening.
Note: for any patient with evidence of impaired glucose control or insulin resistance refer to the Capivasertib Toxicity Management Guidelines.
10. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: a)Absolute neutrophil count \<1.5 × 109/L b)Platelet count \<100 × 109/L c)Haemoglobin \<9 g/dL (\<5.59 mmol/L). \[NOTE: any blood transfusion must be \>14 days prior to the determination of a haemoglobin ≥9 g/dL (≥5.59 mmol/L)\] d)Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \>2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or \>5 × ULN in the presence of liver metastases e)Total bilirubin \>1.5 × ULN (Patients with confirmed Gilbert's syndrome may be included in the study) f)Creatinine \>1.5 × ULN concurrent with creatinine clearance \<50 mL/min (measured or calculated by Cockcroft and Gault formula (using actual body weight) without the need for chronic dialysis therapy.
11. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, or active infection
2. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease. Radiotherapy within 2 weeks prior to the first dose of study intervention. Major surgery (excluding placement of vascular access) within 4 weeks prior to study treatment initiation
3. With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
4. Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation
5. Leptomeningeal metastase
6. Active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
7. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
8. Any of the following cardiac criteria: a)Mean resting QT interval corrected by Fridericia's formula (QTcF) \>470 msec obtained from 3 consecutive ECGs b)History of QT prolongation associated with other medications that required discontinuation of that medication. - Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block) c)Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study based on the Investigator judgement with cardiologist consultation recommended. d)Any factors that increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, clinically significant electrolyte abnormalities including hypokalaemia, hypomagnesaemia, and hypocalcaemia, potential for Torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval e)Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, myocardial infarction, unstable angina pectoris, f)Congestive heart failure New York Heart Association (NYHA) grade ≥2
9. Clinically significant abnormalities of glucose metabolism defined as HbA1c ≥8.0% (63.9 mmol/mol) at screening.
Note: for any patient with evidence of impaired glucose control or insulin resistance refer to the Capivasertib Toxicity Management Guidelines.
10. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: a)Absolute neutrophil count \<1.5 × 109/L b)Platelet count \<100 × 109/L c)Haemoglobin \<9 g/dL (\<5.59 mmol/L). \[NOTE: any blood transfusion must be \>14 days prior to the determination of a haemoglobin ≥9 g/dL (≥5.59 mmol/L)\] d)Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \>2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or \>5 × ULN in the presence of liver metastases e)Total bilirubin \>1.5 × ULN (Patients with confirmed Gilbert's syndrome may be included in the study) f)Creatinine \>1.5 × ULN concurrent with creatinine clearance \<50 mL/min (measured or calculated by Cockcroft and Gault formula (using actual body weight) without the need for chronic dialysis therapy.
11. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, or active infection
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zefei Jiang, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Trial Ethics Committee of The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Baoding, , China
Site Status
RECRUITING
Research Site
Beijing, , China
Site Status
RECRUITING
Research Site
Beijing, , China
Site Status
RECRUITING
Research Site
Beijing, , China
Site Status
RECRUITING
Research Site
Beijing, , China
Site Status
RECRUITING
Research Site
Bengbu, , China
Site Status
RECRUITING
Research Site
Changchun, , China
Site Status
RECRUITING
Research Site
Changsha, , China
Site Status
RECRUITING
Research Site
Changsha, , China
Site Status
RECRUITING
Research Site
Changsha, , China
Site Status
RECRUITING
Research Site
Chengdu, , China
Site Status
RECRUITING
Research Site
Dalian, , China
Site Status
RECRUITING
Research Site
Dalian, , China
Site Status
RECRUITING
Research Site
Deyang, , China
Site Status
RECRUITING
Research Site
Dongguan, , China
Site Status
RECRUITING
Research Site
Foshan, , China
Site Status
RECRUITING
Research Site
Fuzhou, , China
Site Status
RECRUITING
Research Site
Fuzhou, , China
Site Status
RECRUITING
Research Site
Guangzhou, , China
Site Status
RECRUITING
Research Site
Guangzhou, , China
Site Status
NOT_YET_RECRUITING
Research Site
Guangzhou, , China
Site Status
RECRUITING
Research Site
Guiyang, , China
Site Status
RECRUITING
Research Site
Hangzhou, , China
Site Status
RECRUITING
Research Site
Hangzhou, , China
Site Status
RECRUITING
Research Site
Hangzhou, , China
Site Status
RECRUITING
Research Site
Hangzhou, , China
Site Status
RECRUITING
Research Site
Hangzhou, , China
Site Status
RECRUITING
Research Site
Harbin, , China
Site Status
RECRUITING
Research Site
Hefei, , China
Site Status
RECRUITING
Research Site
Hefei, , China
Site Status
RECRUITING
Research Site
Hohhot, , China
Site Status
WITHDRAWN
Research Site
Huizhou, , China
Site Status
RECRUITING
Research Site
Jinan, , China
Site Status
RECRUITING
Research Site
Jinhua, , China
Site Status
RECRUITING
Research Site
Jining, , China
Site Status
RECRUITING
Research Site
Kashgar, , China
Site Status
RECRUITING
Research Site
Kunming, , China
Site Status
RECRUITING
Research Site
Lanzhou, , China
Site Status
WITHDRAWN
Research Site
Linhai, , China
Site Status
RECRUITING
Research Site
Meizhou, , China
Site Status
RECRUITING
Research Site
Nanchang, , China
Site Status
RECRUITING
Research Site
Nanchang, , China
Site Status
RECRUITING
Research Site
Nanchong, , China
Site Status
RECRUITING
Research Site
Nanjing, , China
Site Status
RECRUITING
Research Site
Nanning, , China
Site Status
RECRUITING
Research Site
Ningbo, , China
Site Status
RECRUITING
Research Site
Ningbo, , China
Site Status
RECRUITING
Research Site
Qingdao, , China
Site Status
RECRUITING
Research Site
Shanghai, , China
Site Status
RECRUITING
Research Site
Shanghai, , China
Site Status
RECRUITING
Research Site
Shanghai, , China
Site Status
RECRUITING
Research Site
Shanghai, , China
Site Status
RECRUITING
Research Site
Shantou, , China
Site Status
RECRUITING
Research Site
Shenyang, , China
Site Status
RECRUITING
Research Site
Shenyang, , China
Site Status
RECRUITING
Research Site
Shenzhen, , China
Site Status
RECRUITING
Research Site
Shenzhen, , China
Site Status
RECRUITING
Research Site
Shijiazhuang, , China
Site Status
RECRUITING
Research Site
Sichuan, , China
Site Status
RECRUITING
Research Site
Suining Shi, , China
Site Status
RECRUITING
Research Site
Suzhou, , China
Site Status
RECRUITING
Research Site
Taiyuan, , China
Site Status
RECRUITING
Research Site
Tangshan, , China
Site Status
RECRUITING
Research Site
Tianjin, , China
Site Status
RECRUITING
Research Site
Ürümqi, , China
Site Status
RECRUITING
Research Site
Ürümqi, , China
Site Status
RECRUITING
Research Site
Wanzhou, , China
Site Status
RECRUITING
Research Site
Weifang, , China
Site Status
RECRUITING
Research Site
Wenzhou, , China
Site Status
RECRUITING
Research Site
Wuhan, , China
Site Status
RECRUITING
Research Site
Wuhan, , China
Site Status
RECRUITING
Research Site
Xi'an, , China
Site Status
WITHDRAWN
Research Site
Xi'an, , China
Site Status
RECRUITING
Research Site
Xi'an, , China
Site Status
RECRUITING
Research Site
Xi'an, , China
Site Status
RECRUITING
Research Site
Xiamen, , China
Site Status
RECRUITING
Research Site
Xuzhou, , China
Site Status
RECRUITING
Research Site
Yinchuan, , China
Site Status
RECRUITING
Research Site
Zhanjiang, , China
Site Status
RECRUITING
Research Site
Zhengzhou, , China
Site Status
RECRUITING
Research Site
Zhengzhou, , China
Site Status
RECRUITING
Research Site
Zhengzhou, , China
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
China
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D3612R00016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
NCT06447623
RECRUITING
PHASE3
A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer
NCT04796623
UNKNOWN
PHASE2
Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer
NCT03084939
COMPLETED
PHASE3
A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer
NCT06954961
RECRUITING
PHASE3
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
NCT05646862
ACTIVE_NOT_RECRUITING
PHASE3
A Phase Ib/Ⅱ Study of NTQ1062 in Combination With Fulvestrant in Patients With Advanced HR Positive /HER-2 Negative Breast Cancer
NCT06172322
RECRUITING
PHASE1
Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Patients With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed After Prior Endocrine Therapy
NCT06998108
RECRUITING
PHASE3
A Study of Entinostat in Combination With Fulvestrant for the Treatment of Locally Advanced or Metastatic Breast Cancer
NCT07235618
NOT_YET_RECRUITING
PHASE2
PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
NCT05759546
RECRUITING
PHASE2
Study of the Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Participants With Locally Advanced Inoperable or Metastatic HER2+ Breast Cancer
NCT03153163
COMPLETED
PHASE1
GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer
NCT05054751
COMPLETED
PHASE3
Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer
NCT05759572
RECRUITING
PHASE2
Comparative Effectiveness of Palbociclib Plus AI Versus Fulvestrant for HR+/HER2- ABC
NCT05000736
UNKNOWN
500mg Fulvestrant in HR+ MBC
NCT03708432
COMPLETED
A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain
NCT06764186
ACTIVE_NOT_RECRUITING
PHASE3
Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping
NCT06561022
NOT_YET_RECRUITING
PHASE2
Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy
NCT00570258
TERMINATED
PHASE2
An Exploratory Study of Surufatinib Combined With Chidamide and Fulvestrant in HR Positive Unresectable Metastatic Breast Cancer
NCT05186545
UNKNOWN
PHASE2
A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer
NCT05504213
RECRUITING
PHASE1
Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in HER2-positive MBC
NCT04001634
COMPLETED
Clinical Study of Fulvestrant Combined With Chidamide in the Treatment of Hormone Receptor-positive Advanced Breast Cancer Resistant to CDK4/6 Inhibitors
NCT05191914
UNKNOWN
PHASE4
A Randomized, Controlled, Open-label Clinical Trial of Adjuvant Intensive Therapy for HR+/ HER2-SNF4 Early Breast Cancer
NCT05889871
NOT_YET_RECRUITING
PHASE3
To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer
NCT05365178
ACTIVE_NOT_RECRUITING
PHASE3
Treatment After Progression of Fulvestrant Among Metastatic Breast Cancer Patients
NCT03541863
COMPLETED