Ipatasertib for Triple Negative Breast Neoplasms

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Triple Negative Breast Neoplasms+2 More
Ipatasertib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether adding ipatasertib to atezolizumab and paclitaxel helps people with TNBC that hasn't been treated before.

Eligible Conditions
  • Triple Negative Breast Neoplasms
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Up to 49 months

Up to 49 months
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
Duration of Response (DOR) for participants with PIK3CA/AKT1/PTEN-altered tumors
Investigator-assessed Progression Free Survival (PFS)
Level of Anti-Drug Antibodies (ADAs) (%) to Atezolizumab
Mean and mean changes from baseline score in function in participant-reported Global Health Status (GHS)/Quality of Life (QoL) by assessment timepoint and between treatment arms
Mean and mean changes from baseline score in participant-reported function (role, physical)
Overall Response Rate (ORR)
Overall Response Rate (ORR) for participants with PD-L1-non-positive tumors
Overall Response Rate (ORR) for participants with PIK3CA/AKT1/PTEN-altered tumors
Overall Survival (OS)
Overall Survival (OS) for participants with PD-L1-non-positive tumors
Overall Survival (OS) for participants with PIK3CA/AKT1/PTEN-altered tumors
Percentage of Participants with Adverse Events (AEs)
Plasma concentration of ipatasertib and its metabolite (G037720) (ng/mL) at specified timepoints
Progression Free Survival (PFS) for participants with PIK3CA/AKT1/PTEN-altered tumors
Progression Free Survival (PFS) for participants with Programmed Death-Ligand 1 (PD-L1)-non-positive tumors
Serum concentration of atezolizumab (µg/mL) at specified timepoints

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Ipatasertib and Paclitaxel
92%Diarrhoea
54%Alopecia
52%Nausea
30%Fatigue
28%Rash
28%Myalgia
28%Asthenia
28%Vomiting
26%Peripheral Sensory Neuropathy
21%Insomnia
21%Neutropenia
20%Arthralgia
20%Neuropathy Peripheral
20%Constipation
20%Decreased appetite
18%Headache
18%Dizziness
18%Pyrexia
18%Stomatitis
16%Dermatitis Acneiform
16%Upper Respiratory Tract Infection
15%Pruritus
15%Cough
15%Anaemia
15%Abdominal Pain
15%Dyspnoea
13%Neutrophil Count Decreased
13%Nasopharyngitis
13%Dyspepsia
11%Epistaxis
11%Back Pain
11%Oedema Peripheral
10%Paraesthesia
10%Hypercholesterolaemia
8%Urinary Tract Infection
8%Pain in Extremity
8%Hot Flush
8%Aspartate Aminotransferase Increased
8%Hyperglycaemia
7%Nail Disorder
7%Onycholysis
7%Dysgeusia
7%Flushing
7%Musculoskeletal Chest Pain
7%Chest Discomfort
7%Gastritis
7%Hypoaesthesia
7%Abdominal Pain Upper
7%Rhinitis
7%Flatulence
7%Dry Eye
7%Mucosal Inflammation
7%Productive cough
7%Chest Pain
7%Influenza
7%Bone pain
7%Hypokalaemia
7%Depression
5%Pneumonia
5%Alanine Aminotransferase Increased
5%Musculoskeletal Pain
5%Hypertension
3%Anxiety
3%Febrile Neutropenia
3%Leukopenia
3%Dry Mouth
2%Decreased Appetite
2%Pancreatitis
2%Atypical Pneumonia
2%Retroperitoneal Infection
2%Spinal Cord Compression
2%Embolism
2%Wound Infection
2%Tuberculosis
2%Vascular device infection
2%Rash Maculo-Papular
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT02162719) in the Ipatasertib and Paclitaxel ARM group. Side effects include: Diarrhoea with 92%, Alopecia with 54%, Nausea with 52%, Fatigue with 30%, Rash with 28%.

Trial Design

5 Treatment Groups

Cohort 1 Arm C
1 of 5
Cohort 2 Arm B
1 of 5
Cohort 1 Arm B
1 of 5
Cohort 2 Arm A
1 of 5
Cohort 1 Arm A
1 of 5

Active Control

Experimental Treatment

242 Total Participants · 5 Treatment Groups

Primary Treatment: Ipatasertib · Has Placebo Group · Phase 3

Cohort 1 Arm BExperimental Group · 3 Interventions: Ipatasertib, Placebo for Atezolizumab, Paclitaxel · Intervention Types: Drug, Drug, Drug
Cohort 2 Arm AExperimental Group · 3 Interventions: Ipatasertib, Atezolizumab, Paclitaxel · Intervention Types: Drug, Drug, Drug
Cohort 1 Arm AExperimental Group · 3 Interventions: Ipatasertib, Atezolizumab, Paclitaxel · Intervention Types: Drug, Drug, Drug
Cohort 1 Arm CActiveComparator Group · 3 Interventions: Placebo for Atezolizumab, Placebo for Ipatasertib, Paclitaxel · Intervention Types: Drug, Drug, Drug
Cohort 2 Arm BActiveComparator Group · 3 Interventions: Atezolizumab, Placebo for Ipatasertib, Paclitaxel · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipatasertib
Not yet FDA approved
Atezolizumab
FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 49 months

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,353 Previous Clinical Trials
1,093,866 Total Patients Enrolled
20 Trials studying Triple Negative Breast Neoplasms
8,415 Patients Enrolled for Triple Negative Breast Neoplasms
Clinical TrialsStudy DirectorHoffmann-La Roche
2,135 Previous Clinical Trials
901,389 Total Patients Enrolled
15 Trials studying Triple Negative Breast Neoplasms
6,797 Patients Enrolled for Triple Negative Breast Neoplasms

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to complete all study-related assessments, including PRO assessments, in the investigator's judgement.
Breast cancer that is locally advanced or metastatic and is not amenable to resection with curative intent.
You have a performance status of 0 or 1.
You are eligible for paclitaxel monotherapy if tumor PD-L1 status is unknown or non-positive; appropriate candidate for paclitaxel and atezolizumab if tumor PD-L1 status is positive.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: November 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.