Breast CancerPhase 3CAPItrueNCT06635447
Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients
A Phase 3 study testing Capivasertib and Fulvestrant in people with Breast Cancer, run by AstraZeneca at 76 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Capivasertib and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 76 sitesChina
- Study dates
- 26 Sep 2024to 10 Jan 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.
- Patients must be aged ≥18 years at the time of signing the ICF
- 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
- 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%).
Show all 12Show fewer
- Patients must have at least 1 measurable lesion.
- Patients must be eligible for fulvestrant therapy as per local investigator assessment.
- Consent to submit and provide a mandatory FFPE tumour sample for central testing.
- Patients must be able to swallow and retain oral medication.
- Eastern Cooperative Oncology Group (ECOG)/ World Health Organisation (WHO) performance status 0 or 1 and life expectancy of ≥12 weeks.
- Patients with PIK3CA/AKT1/PTEN alterations confirmed by central laboratory NGS testing. (Note: Applicable exclusively to patients enrolled under Protocol Version 2.0.)
Who cannot join
- 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)
- 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
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation
- Leptomeningeal metastase
- Active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
Show all 29Show fewer
- 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
- 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
- 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.
- 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.
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, or active infection
- Known HIV infection that is not well controlled. (All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load, CD4+ count of >350, no history of AIDS-defining opportunistic infection within the past 12 months, and on anti-HIV medications for at least 4 weeks. Teams should consider adding appropriate information into sections for AE monitoring and the concomitant medication tables.[HIV inclusion criteria may be adjusted to lower CD4+ count values if clinically indicated if the patient has a potentially curable malignancy or for interventions in a later stage of development that have demonstrated prior activity within a given cancer, please adjust if necessary.])
- 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.
- Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or LHRH agonist (if applicable)
- 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
- Previous allogenic bone marrow or solid organ transplant
- Known immunodeficiency syndrome
- 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)
- 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.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- 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.
- 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
- 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.
- 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.)
- 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.
- Pregnant women (confirmed with positive pregnancy test) or breast-feeding women or women who are planning to become pregnant.
Trial locations and contacts
76 sites in 1 country.
76 sites in 1 country
China76 sites
Research Site
Baoding, 071000
Research Site
Beijing, 100021
Research Site
Beijing, 100071
Research Site
Beijing, 100730
Research Site
Beijing, CN-100730
Research Site
Bengbu, 233004
Research Site
Changchun, 130021
Research Site
Changsha, 410008
Research Site
Changsha, 410011
Research Site
Changsha, 410013
Research Site
Chengdu, 610072
Research Site
Dalian, 116001
Research Site
Dalian
Research Site
Deyang, 618000
Research Site
Dongguan, 523009
Research Site
Foshan, 528000
Research Site
Fuzhou, 350001
Research Site
Fuzhou, 350011
Research Site
Guangzhou, 510060
Research Site
Guangzhou, 510120
Research Site
Guiyang, 550044
Research Site
Hangzhou, 310003
Research Site
Hangzhou, 310009
Research Site
Hangzhou, 310016
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Hefei, 230022
Research Site
Hefei, 230031
Research Site
Huizhou, 516001
Research Site
Jinan, 250012
Research Site
Jinhua
Research Site
Jining, 272029
Research Site
Jinzhou, 121001
Research Site
Kashgar, 844099
Research Site
Kunming, 650118
Research Site
Linhai, 317000
Research Site
Meizhou, 514031
Research Site
Nanchang, 330009
Research Site
Nanchong, 637000
Research Site
Nanjing, 210029
Research Site
Ningbo, 315099
Research Site
Ningbo, 315100
Research Site
Qingdao, 266042
Research Site
Shanghai, 200025
Research Site
Shanghai, 200080
Research Site
Shanghai, 201114
Research Site
Shanghai, 201210
Research Site
Shantou, 515063
Research Site
Shenyang, 110004
Research Site
Shenyang, 110042
Research Site
Shenzhen, 518020
Research Site
Shenzhen, 518036
Research Site
Shijiazhuang, 050020
Research Site
Sichuan, 610041
Research Site
Suining Shi, 629000
Research Site
Suzhou, 215004
Research Site
Taiyuan, 030000
Research Site
Tangshan, 063001
Research Site
Tianjin, 300060
Research Site
Ürümqi, 830000
Research Site
Ürümqi, 830054
Research Site
Wanzhou, 404000
Research Site
Weifang, 261000
Research Site
Wenzhou, 325000
Research Site
Wuhan, 430022
Research Site
Wuhan, 430030
Research Site
Xi'an, 710000
Research Site
Xi'an, 710006
Research Site
Xi'an, 710061
Research Site
Xiamen, 361003
Research Site
Xuzhou, 221005
Research Site
Yinchuan, 750000
Research Site
Zhanjiang, 524004
Research Site
Zhengzhou, 450000
Research Site
Zhengzhou, 450008
Research Site
Zhengzhou, 450052
About this study
Official title: A Phase IIIb Single Arm, 2 Cohorts Study Assessing the Efficacy and Safety of Capivasertib+ Fulvestrant as Treatment for Locally Advanced(Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With Endocrine Therapy in Chinese Patients
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Capivasertib, Fulvestrant
- Keywords
- Breast Cancer, HR+/HER2-ABC, disease recurrence/progression
- Medical subject headings
- Breast Neoplasms, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapivasertibDrug
Also called AZD5363
400 mg, oral, twice daily; 4 days on and 3 days off
FulvestrantDrug
Fulvestrant IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Capivasertib+Fulvestrant Receives: Drug: Capivasertib; Drug: Fulvestrant |
| Cohort 2 | Experimental | Capivasertib+Fulvestrant Receives: Drug: Capivasertib; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first subsequent treatment (TFST) of PIK3CA/AKT1/PTEN-altered population in Cohort 1
To assess the efficacy of capi+ful by assessment of TFST (Time to first subsequent treatment) of PIK3CA/AKT1/PTEN-altered subgroup in cohort1
Measured: From the first dose of study intervention to the earlier of start date of the first subsequent therapy after discontinuation of study intervention, or death in PIK3CA/AKT1/PTEN-altered population in Cohort 1, up to approximately 2 years
Secondary outcomes (5)
Progression-free survival (PFS) in PIK3CA/AKT1/PTEN-altered population in Cohort 1 and 2
To assess the efficacy of capi+ful by assessment of PFS of PIK3CA/AKT1/PTEN-altered population in Cohort 1 and 2
Measured: From first dose until objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from study treatment or receives another anti-cancer therapy before progression, up to 2 years
Time to first subsequent treatment (TFST) in PIK3CA/AKT1/PTEN-altered population in Cohort 2
To assess the efficacy of capi+ful by assessment of TFST in PIK3CA/AKT1/PTEN-altered population in Cohort 2
Measured: From the first dose of study intervention to the earlier of start date of the first subsequent therapy after discontinuation of study intervention, or death in PIK3CA/AKT1/PTEN-altered population in Cohort 2, up to approximately 2 years
Number of participants with AEs/SAEs
To assess the safety and tolerability of capivasertib + fulvestrant in cohort1 and cohort2
Measured: From time of signature of the ICF, throughout the treatment period and including the 30-day follow-upperiod after discontinuation of study drug, up to approximately 2 years
Objective response rate (ORR) in PIK3CA/AKT1/PTEN-altered population in Cohort 1 and 2
To assess the efficacy of capi+ful by assessment of ORR of PIK3CA/AKT1/PTEN-altered population in Cohort 1 and 2
Measured: From first dose of study intervention until objective disease progression, death, or start of a new anti-cancer therapy, assessed every 8 weeks (±7 days) for the first 18 months and every 12 weeks (±7 days) thereafter, up to approximately 2 years.
Number of participants with AEs/SAEs in PIK3CA/AKT1/PTEN-altered population
To assess the safety and tolerability of capivasertib + fulvestrant of PIK3CA/AKT1/PTEN-altered population in Cohort 1 and Cohort 2
Measured: From time of signature of the ICF, throughout the treatment period and including the 30-day follow-upperiod after discontinuation of study drug in PIK3CA/AKT1/PTEN-altered population, up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start26 Sep 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion10 Jan 2027 (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 AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zefei Jiang, PhD, Principal investigator, Clinical Trial Ethics Committee of The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635447
- Sponsor's protocol ID
- D3612R00016
- Acronym
- CAPItrue
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient- level data from AstraZeneca group of companies sponsored clinical trials via the request portal. Plan Description: All request will be evaluated as per the Az disclosure commitment: https://astrazenecaarouptrials.pharmacm.com/ST/Submission/Disclosure Yes. indicates that Az are accepting requests for IPD ,but this does not mean are quests will be shared
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb Single Arm, 2 Cohorts Study Assessing the Efficacy and Safety of Capivasertib+ Fulvestrant as Treatment for Locally Advanced(Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With Endocrine Therapy in Chinese Patients
- ClinicalTrials.gov ID
- NCT06635447
- Acronym / sponsor ID
- CAPItrue / D3612R00016
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, HR+/HER2-ABC, disease recurrence/progression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 293 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 10 Oct 2024 (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 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.
Detailed description
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.
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 | Experimental | Drug: Capivasertib, Drug: FulvestrantCapivasertib+Fulvestrant |
| Cohort 2 | Experimental | Drug: Capivasertib, Drug: FulvestrantCapivasertib+Fulvestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
- Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.
- Patients must be aged ≥18 years at the time of signing the ICF
- 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
- 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.
Key exclusion criteria (29 listed)
- 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)
- 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
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation
- Leptomeningeal metastase
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 |
|---|---|---|
| CapivasertibAlso: AZD5363400 mg, oral, twice daily; 4 days on and 3 days off | Drug | Cohort 1, Cohort 2 |
| FulvestrantFulvestrant IV | Drug | Cohort 1, Cohort 2 |
Primary outcome
Time to first subsequent treatment (TFST) of PIK3CA/AKT1/PTEN-altered population in Cohort 1
Time frame: From the first dose of study intervention to the earlier of start date of the first subsequent therapy after discontinuation of study intervention, or death in PIK3CA/AKT1/PTEN-altered population in Cohort 1, up to approximately 2 years
To assess the efficacy of capi+ful by assessment of TFST (Time to first subsequent treatment) of PIK3CA/AKT1/PTEN-altered subgroup in cohort1
5 secondary outcomes
Progression-free survival (PFS) in PIK3CA/AKT1/PTEN-altered population in Cohort 1 and 2
Time frame: From first dose until objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from study treatment or receives another anti-cancer therapy before progression, up to 2 years
Time to first subsequent treatment (TFST) in PIK3CA/AKT1/PTEN-altered population in Cohort 2
Time frame: From the first dose of study intervention to the earlier of start date of the first subsequent therapy after discontinuation of study intervention, or death in PIK3CA/AKT1/PTEN-altered population in Cohort 2, up to approximately 2 years
Number of participants with AEs/SAEs
Time frame: From time of signature of the ICF, throughout the treatment period and including the 30-day follow-upperiod after discontinuation of study drug, up to approximately 2 years
Objective response rate (ORR) in PIK3CA/AKT1/PTEN-altered population in Cohort 1 and 2
Time frame: From first dose of study intervention until objective disease progression, death, or start of a new anti-cancer therapy, assessed every 8 weeks (±7 days) for the first 18 months and every 12 weeks (±7 days) thereafter, up to approximately 2 years.
Number of participants with AEs/SAEs in PIK3CA/AKT1/PTEN-altered population
Time frame: From time of signature of the ICF, throughout the treatment period and including the 30-day follow-upperiod after discontinuation of study drug in PIK3CA/AKT1/PTEN-altered population, up to approximately 2 years
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 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient- level data from AstraZeneca group of companies sponsored clinical trials via the request portal. Plan Description: All request will be evaluated as per the Az disclosure commitment: https://astrazenecaarouptrials.pharmacm.com/ST/Submission/Disclosure Yes. indicates that Az are accepting requests for IPD ,but this does not mean are quests will be shared
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.
Zefei Jiang, PhD principal investigator
Clinical Trial Ethics Committee of The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
76 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capivasertib and Fulvestrant in people with Breast Cancer, run by AstraZeneca at 76 sites 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 12 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites 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 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?
Time to first subsequent treatment (TFST) of PIK3CA/AKT1/PTEN-altered population in Cohort 1 (time frame: From the first dose of study intervention to the earlier of start date of the first subsequent therapy after discontinuation of study intervention, or death in PIK3CA/AKT1/PTEN-altered population in Cohort 1, up to approximately 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 17 Aug 2026.