A Phase Ib/III Randomised Study of Capivasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

  • End date
    Jan 3, 2028
  • participants needed
  • sponsor
Updated on 23 October 2022


A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)


This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with palbociclib and fulvestrant in participants with endocrine-resistant locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capivasertib + fulvestrant and of palbociclib + fulvestrant are established, the dose and schedule for the triplet combination (capivasertib + palbociclib + fulvestrant) needs to be confirmed. Therefore, the initial dose finding Phase Ib part of the study will confirm the recommended Phase III doses (RP3D) and schedule of administration of capivasertib and palbociclib for the triplet combination including fulvestrant which will then be used in the Phase III part of this study.

Condition Locally Advanced (Inoperable) or Metastatic Breast Cancer
Treatment fulvestrant, Palbociclib, Capivasertib, Capivasertib Placebo, Matched Capivasertib Placebo
Clinical Study IdentifierNCT04862663
Last Modified on23 October 2022


Yes No Not Sure

Inclusion Criteria

Adult females (pre- and/or post-menopausal), and adult males
Histologically confirmed HR+/ HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) per the American Society of Clinical Oncology and College of American Pathologists guideline. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor
Eligible for palbociclib and fulvestrant therapy as per investigator assessment. Previous tolerance to specific CDK4/6 inhibitors and dose levels required
Adequate organ and bone marrow functions
Consent to provide a mandatory FFPE tumour sample
Inclusion criteria only for phase III
Previous treatment with an ET (tamoxifen or an AI) as a single agent or in combination, with
Received up to a maximum of 1 lines of prior chemotherapy in the advanced setting
radiological evidence of breast cancer recurrence or progression while on, or within 12 months of, completing a (neo)adjuvant ET regimen OR
radiological evidence of progression while receiving the ET for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy)

Exclusion Criteria

Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment
History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence
Persistent toxicities (CTCAE Grade >1) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss) after consultation with the AstraZeneca study physician
Radiotherapy with a wide field of radiation within 4 weeks prior to study treatment initiation and/or radiotherapy with a limited field of radiation for palliation within 2 weeks prior to study treatment initiation. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible independent of when it was received
Spinal cord compression, brain metastases or leptomeningeal metastases unless asymptomatic, treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation
Any of the following cardiac criteria at screening
Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 consecutive ECGs
Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block)
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
Uncontrolled hypotension
Cardiac ejection fraction outside institutional range of normal or < 50% (whichever is higher)
Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥ 2
Any of these clinically significant abnormalities of glucose metabolism at screening
diabetes mellitus type I or type II requiring insulin treatment
Previous allogeneic bone marrow transplant or solid organ transplant
Key exclusion criteria for the phase III only
HbA1c ≥ 8.0% (63.9 mmol/mol)
Any prior treatment with SERDs, AKT, PI3K or mTOR inhibitors
Prior treatment with CDK4/6 inhibitors in the metastatic setting (prior CDK4/6 inhibitors permitted in the adjuvant setting)
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