Regulatory approval

Published by the Health Canada.

Health Canada approved capivasertib, in combination with fulvestrant, for the treatment of adult females with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

This is written in the approval document as:

TRUQAP (capivasertib tablets), in combination with fulvestrant, is indicated for the treatment of adult females with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Citation

AstraZeneca Canada Inc. Truqap (capivasertib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00078178.PDF. Revised January 2025. Accessed June 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	HER2-negative, PIK3CA somatic variants, PR positive	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PIK3CA somatic variants, PR positive	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	AKT1 somatic variants, ER positive, HER2-negative	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	AKT1 somatic variants, HER2-negative, PR positive	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	AKT1 somatic variants, ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	AKT1 amplification, ER positive, HER2-negative	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	AKT1 amplification, HER2-negative, PR positive	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	AKT1 amplification, ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PTEN nonsense variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	HER2-negative, PR positive, PTEN nonsense variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PR positive, PTEN nonsense variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PTEN frameshift variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	HER2-negative, PR positive, PTEN frameshift variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PR positive, PTEN frameshift variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PTEN splice site variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	HER2-negative, PR positive, PTEN splice site variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PR positive, PTEN splice site variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PTEN deletion	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	HER2-negative, PR positive, PTEN deletion	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PR positive, PTEN deletion	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PIK3CA amplification	Invasive Breast Carcinoma	Capivasertib, Fulvestrant