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PD-L1 Inhibitor
Ipatasertib Combinations for Breast Cancer
Phase 1 & 2
Waitlist Available
Led By Yuan Yuan
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial is testing a new drug, ipatasertib, to see if it can help treat triple negative breast cancer. Ipatasertib works by blocking some of the enzymes needed for cell growth. The trial will test different combinations of ipatasertib with other drugs to see which works best.
Who is the study for?
This trial is for adults with metastatic triple negative breast cancer. Participants must have a good performance status, adequate organ function, and no more than two prior chemotherapy treatments in the metastatic setting. They should not have had certain previous treatments that could affect the study results or be pregnant/breastfeeding. Men and women must agree to contraception.Check my eligibility
What is being tested?
The trial tests ipatasertib combined with carboplatin alone or with paclitaxel/capecitabine/atezolizumab to see which works best against this type of breast cancer. Ipatasertib blocks enzymes needed for cell growth, while other drugs kill or stop cells from dividing/spreading.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation (like inflammation), typical chemotherapy side effects such as nausea, fatigue, low blood counts leading to increased infection risk, and potential liver enzyme changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Clinical Benefit Rate
Overall Response
Overall Survival (OS)
Other outcome measures
Association of stool microbiome, calprotectin with diarrhea
Association of triple negative breast cancer (TBNC) messenger ribonucleic acid (RNA) expression profiling
Genomic immune biomarkers and its association with response
+4 moreSide effects data
From 2023 Phase 3 trial • 242 Patients • NCT0417710874%
Diarrhoea
40%
Nausea
35%
Neutropenia
35%
Anaemia
35%
Neuropathy peripheral
26%
Alanine aminotransferase increased
23%
Alopecia
23%
Hyperglycaemia
23%
Rash
21%
Asthenia
19%
Fatigue
16%
Constipation
16%
Aspartate aminotransferase increased
16%
Vomiting
14%
Mucosal inflammation
14%
Pyrexia
14%
Decreased appetite
12%
Paraesthesia
12%
Abdominal pain upper
12%
Neutrophil count decreased
12%
White blood cell count decreased
12%
Myalgia
12%
Blood alkaline phosphatase increased
12%
Blood creatinine increased
9%
Dizziness
9%
Cough
9%
Rhinorrhoea
9%
Urticaria
9%
Leukopenia
9%
Gamma-glutamyltransferase increased
9%
Peripheral sensory neuropathy
9%
Weight decreased
9%
Hypokalaemia
9%
Arthralgia
9%
Insomnia
7%
Epistaxis
7%
Hypomagnesaemia
7%
Lymphocyte count decreased
7%
Stomatitis
7%
Back pain
7%
Dyspepsia
7%
Urinary tract infection
7%
Infusion related reaction
7%
Illness
7%
Pruritus
7%
Hyperbilirubinaemia
7%
Lymphoedema
7%
Abdominal discomfort
7%
Gastrooesophageal reflux disease
5%
Cellulitis
5%
Septic shock
5%
Polyneuropathy
5%
COVID-19
5%
Hyponatraemia
5%
Headache
5%
Abdominal pain
5%
Oedema peripheral
5%
Hypothyroidism
5%
Bone pain
5%
Dyspnoea
5%
Erythema
5%
Blood glucose increased
5%
Lymphopenia
2%
Musculoskeletal pain
2%
Cholecystitis infective
2%
Pyelonephritis
2%
Blood albumin decreased
2%
Gastritis
2%
Glycosylated haemoglobin increased
2%
Hypernatraemia
2%
Dehydration
2%
COVID-19 pneumonia
2%
Hypersensitivity
2%
Upper gastrointestinal haemorrhage
2%
Clostridium difficile colitis
2%
Drug eruption
2%
Lipase increased
2%
Hypocalcaemia
2%
Pleural effusion
2%
Hyperkalaemia
2%
Eczema
2%
Accidental overdose
2%
Acute kidney injury
2%
Blood lactate dehydrogenase increased
2%
Blood cholesterol increased
2%
Rash maculo-papular
2%
Dry mouth
2%
Neurotoxicity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxe
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (ipatasertib, capecitabine, atezolizumab)Experimental Treatment5 Interventions
Patients receive ipatasertib PO QD on days 1-21, capecitabine PO BID on days 1-7 and 15-21, and atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (ipatasertib, carboplatin, paclitaxel)Experimental Treatment5 Interventions
Patients receive ipatasertib PO QD on days 1-28. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 60 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group III: Arm B (ipatasertib and carboplatin)Active Control4 Interventions
Patients receive ipatasertib PO QD on days 1-28. Patients also receive carboplatin IV over 30 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Capecitabine
FDA approved
Carboplatin
FDA approved
Ipatasertib
Not yet FDA approved
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,432 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,639 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Yuan YuanPrincipal InvestigatorCity of Hope Medical Center
6 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 3 more months.If you are a man with a female partner who can have children, you need to either not have sex or use a condom during the clinical trial and for six months after the trial is over. You also cannot donate sperm during this time to avoid the risk of pregnancy.You have received immune checkpoint inhibitors before in Arm C.You have received a transplant of stem cells or an organ from another person.You have any other medical condition or laboratory result that would make taking the experimental drug unsafe or could affect the accuracy of the study results.You have received certain types of immunotherapy such as CD137 agonists or drugs that target immune checkpoints like anti-CTLA-4, anti-PD-1, and anti-PD-L1.You cannot have received a live vaccine 4 weeks before starting treatment, during treatment, or 5 months after your last dose of atezolizumab for Arm C.You are experiencing unmanageable pain related to your tumor.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (ipatasertib, carboplatin, paclitaxel)
- Group 2: Arm B (ipatasertib and carboplatin)
- Group 3: Arm C (ipatasertib, capecitabine, atezolizumab)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any previous researches explored the potential of Ipatasertib?
"At the time of this writing, 1739 trials for Ipatasertib have been initiated. Of those active studies, 487 are in Phase 3. While primarily hosted in Guangzhou, Guangdong, there are a total of 90244 sites across the globe conducting research on this treatment."
Answered by AI
Is it still possible to join the experiment as a participant?
"This clinical trial has concluded its recruitment phase as of August 15th, 2022. It had originally been posted on March 4th 2019. Currently, there are 2351 trials dedicated to breast cancer and 1739 that focus on Ipatasertib treatment actively seeking participants."
Answered by AI
What maladies is Ipatasertib typically prescribed to address?
"Ipatasertib is a well-known therapeutic option for metastatic ureter urothelial carcinoma, but can also be beneficial in the initial treatment of lymphomas, non-Hodgkin's disease and locally advanced non-small cell lung cancers."
Answered by AI
How many participants are currently being enrolled in this clinical research project?
"Unfortunately, this trial is not currently enrolling. It was posted on the 4th of March 2019 and last updated on the 15th of August 2022. If you are searching for alternative clinical trials, 2351 studies with breast cancer as a focus area and 1739 involving Ipatasertib are actively recruiting patients."
Answered by AI
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