Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor

  • End date
    Dec 31, 2026
  • participants needed
  • sponsor
    Canadian Cancer Trials Group
Updated on 23 July 2021
advanced breast cancer
aromatase inhibitor
estrogen receptor


The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant).


Patients enrolled in this study will receive either Ipatasertib plus Fulvestrant or placebo (a substance that looks like the study drug but does not have any active or medicinal ingredient) plus Fulvestant. The study will provide information about the ability of Ipatasertib plus Fulvestrant to control the cancer, the side effects and safety of the treatment, how patients feel while taking the treatment and associated costs.

Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Placebo, fulvestrant, Ipatasertib
Clinical Study IdentifierNCT04650581
SponsorCanadian Cancer Trials Group
Last Modified on23 July 2021


Yes No Not Sure

Inclusion Criteria

Histologically and/or cytologically confirmed ER positive, HER-2 negative breast cancer
Female patients must be post-menopausal; female patients who are pre-menopausal must have ovarian suppression using LHRH agonist while on study
Clinical and/or radiographic progression during treatment with or within 28 days after discontinuation of first line of treatment with a CDK 4/6 inhibitor and an aromatase inhibitor (AI) for advanced/metastatic disease
Evidence of clinically and/or radiologically documented disease
years of age
ECOG performance status of 0 or 1
No concurrent anti-cancer therapy and must satisfy the following criteria for previous therapy
Must not have received more than one prior line of treatment with a CDK 4/6 inhibitor and an AI in the advanced disease setting
Treatment with CDK 4/6 inhibitor and AI must have been the most recent treatment prior to registration for this study
Adequate hematology and organ function, in the absence of growth factors
Absolute neutrophils > 1.5 x 10^9/L
Platelets 100 x 10^9/L
Hemoglobin > 90 g/L
Total Bilirubin 1.5 x ULN (upper limit of normal) or 3 x ULN if confirmed Gilbert's Syndrome
ALT and AST 2.5 x ULN (or 5.0 x ULN if liver or bone metastasis)
Alkaline phosphatase 2.0 x ULN (or 5.0 x ULN if liver metastases, 7.0 x ULN if bone metastasis)
Fasting glucose 8.3 mmol/L
HbA1c 7.5%
Serum albumin 30 g/L
INR 1.2
Serum Creatinine or Creatinine clearance 1.5 x ULN or 50 mL/min; measured directly by 24-hour urine sampling or as calculated by Crockcroft and Gault equation

Exclusion Criteria

Untreated or symptomatic CNS metastases, radiation treatment for CNS metastases within 28 days
Active inflammatory bowel disease, bowel inflammation, inability to swallow oral medication or GI condition that alters oral absorption
Prior treatment with fulvestrant, selective estrogen receptor degraders (SERDs) or known inhibitors of the PI3K pathway including PI3K inhibitors, AKT inhibitors, or mTOR inhibitors
Mean QT interval corrected for heart rate (QTc) 480 msec by ECG or history of familial long QT syndrome
Active or uncontrolled infections or serious illnesses or medical conditions
Clinically significant liver diseases
History of lung disease or history of opportunistic infections
Type 1 or Type 2 diabetes mellitus requiring insulin
Grade 2 uncontrolled hypercholesterolemia or hypertriglyceridemia
Known abnormalities in coagulation
History of hypersensitivity to the study drugs or components
Pregnant or lactating women
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