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Hormone Therapy

Ipatasertib + Endocrine Therapy for Breast Cancer

Phase 1

Waitlist Available

Led By Aditya Bardia, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Premenopausal/perimenopausal women on gonadotropin-releasing hormone agonist (to be continued during study) and estradiol level in the postmenopausal range according to institutional standards

Adequate renal function: Calculated creatinine clearance ≥ 30 mL/min

Must not have

Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including any of the following:

For Arm C only: h/o of intolerable toxicity to CDK 4/6 inhibitor resulting in treatment discontinuation due to toxicity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for breast cancer.

Who is the study for?

This trial is for postmenopausal women with advanced or metastatic hormone receptor-positive, HER2-negative breast cancer. They must have had disease progression after prior therapy and should not be on certain antiretroviral therapies or have uncontrolled illnesses. Women of childbearing potential are excluded unless they use effective contraception.

What is being tested?

The TAKTIC study tests if Ipatasertib combined with an Aromatase inhibitor or Fulvestrant improves outcomes in breast cancer treatment. It's designed to see how well patients respond to this combination compared to their previous treatments.

What are the potential side effects?

Potential side effects may include gastrointestinal issues, changes in blood sugar levels, fatigue, liver function alterations, and possible heart complications. The severity can vary from mild discomforts to more serious conditions requiring medical attention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a premenopausal woman on hormone therapy with low estrogen levels.

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My kidneys are working well enough (creatinine clearance ≥ 30 mL/min).

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I have had both of my ovaries surgically removed.

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I am a postmenopausal woman with advanced or metastatic breast cancer.

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My cancer has worsened after treatment, including hormone therapy.

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My liver functions are within the required range.

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I am able to care for myself and perform daily activities.

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My blood tests show normal white blood cells, hemoglobin, and platelets.

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I am a woman over 18 with HR+/HER2- breast cancer, confirmed by biopsy.

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My LH and FSH levels indicate I am postmenopausal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled heart disease or abnormal heart rhythms.

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I stopped taking CDK 4/6 inhibitor due to severe side effects.

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I am not pregnant.

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I use a highly effective form of birth control.

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I have previously used an AKT inhibitor.

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I do not have any serious illnesses or mental health issues that would stop me from following the study rules.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events

Secondary study objectives

Complete Response

Overall Response Rate

Overall Survival

+2 more

Side effects data

From 2024 Phase 3 trial • 1101 Patients • NCT03072238

79%

Diarrhoea

38%

Hyperglycaemia

28%

Nausea

26%

Rash

22%

Fatigue

20%

Alanine aminotransferase increased

19%

Anaemia

18%

Decreased appetite

18%

Asthenia

17%

Vomiting

17%

Aspartate aminotransferase increased

15%

Back pain

14%

Hypertension

13%

Oedema peripheral

12%

Weight decreased

12%

Arthralgia

10%

Headache

Rash maculo-papular

Hypokalaemia

Pruritus

Constipation

Nasopharyngitis

Cough

Urinary tract infection

Pain in extremity

Upper respiratory tract infection

Bone pain

Dizziness

Blood creatinine increased

Dyspepsia

Hypertriglyceridaemia

Abdominal pain

Pyrexia

Fall

Haematuria

Dyspnoea

Hot flush

Musculoskeletal pain

Insomnia

Pneumonia

Dehydration

Erythema multiforme

Cardiac failure

Cellulitis

Sepsis

Acute kidney injury

Nephrolithiasis

Acute myocardial infarction

Myocardial infarction

Death

Pulmonary embolism

Septic shock

Deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + Abiraterone

Ipatasertib + Abiraterone

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Fulvestrant + Ipatasertib +PalbociclibExperimental Treatment3 Interventions

* Ipatasertib will be administered orally on a 3 week on and 1 week off schedule * Fulvestrant would be administered as intra-muscular injection twice a month for the first cycle, and then monthly for all other cycles. * Palbociclib will be administered orally on a 3 week on and 1 week off schedule

Group II: Fulvestrant + IpatasertibExperimental Treatment2 Interventions

* Ipatasertib will be administered orally on a daily basis * Fulvestrant would be administered as intra-muscular injection twice a month for the first cycle, and then monthly for all other cycles.

Group III: Aromatase Inhibitor + IpatasertibExperimental Treatment2 Interventions

* Ipatasertib will be administered orally on a daily basis * Aromatase inhibitors will be administered orally on a daily basis

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipatasertib

Not yet FDA approved

Fulvestrant

FDA approved

Letrozole

FDA approved