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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
My cancer has worsened after treatment, including hormone therapy.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Complete Response
Overall Response Rate
Overall Survival
+2 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
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
Palbociclib
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,278 Total Patients Enrolled
80 Trials studying Breast Cancer
132,835 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,612 Total Patients Enrolled
96 Trials studying Breast Cancer
23,141 Patients Enrolled for Breast Cancer
Aditya Bardia, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital, Massachusetts General Physicians Organization Inc
All India Inst Of Medical Sci (Medical School)
Mayo Grad School Med/Mayo Fndn (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain metastases are stable, and I haven't taken steroids for over a month.I have previously been treated with mTOR or PI3K inhibitors.I am a premenopausal woman on hormone therapy with low estrogen levels.I have at least one cancer lesion that can be measured.I practice total abstinence as my usual form of lifestyle.I am using or will use effective birth control during and 8 weeks after the study.I am a woman who has been sterilized through surgery at least six weeks ago.I do not have uncontrolled heart disease or abnormal heart rhythms.I haven't taken strong CYP3A affecting drugs in the last 14 days or longer.My kidneys are working well enough (creatinine clearance ≥ 30 mL/min).I have had both of my ovaries surgically removed.I have diabetes requiring insulin or stable oral medication for at least 2 weeks.I have previously taken aromatase inhibitors.I stopped taking CDK 4/6 inhibitor due to severe side effects.I am a postmenopausal woman with advanced or metastatic breast cancer.I am not pregnant.Your blood sugar levels when you haven't eaten should be below 140 mg/dL, and your average blood sugar over the past few months should be less than 7.My cancer has worsened after treatment, including hormone therapy.I am HIV-positive and not on combination antiretroviral therapy.My liver functions are within the required range.I am a woman 60 years old or younger.I have previously been treated with fulvestrant.I use a highly effective form of birth control.I have previously used an AKT inhibitor.I am a woman older than 60 years.Your heart's pumping ability is normal, and it's above 50%.I am able to care for myself and perform daily activities.I stopped my breast cancer treatments 14-28 days ago, depending on the type.My blood tests show normal white blood cells, hemoglobin, and platelets.I haven't had chemotherapy or radiotherapy in the last 4 weeks, or I've recovered from its side effects.I am a woman over 18 with HR+/HER2- breast cancer, confirmed by biopsy.My LH and FSH levels indicate I am postmenopausal.I do not have any serious illnesses or mental health issues that would stop me from following the study rules.
Research Study Groups:
This trial has the following groups:- Group 1: Fulvestrant + Ipatasertib
- Group 2: Aromatase Inhibitor + Ipatasertib
- Group 3: Fulvestrant + Ipatasertib +Palbociclib
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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.
Are recruitment activities in progress for this experiment?
"Affirmative. Clinicaltrials.gov currently displays that this clinical trial, which was first submitted on May 30th 2019 and recently revised October 25th 2021, is actively seeking participants. This study requires 60 people to be enrolled at one site."
Answered by AI
What indications are typically addressed with Ipatasertib?
"Ipatasertib is an effective therapeutic option for cases in which disease progression has been identified. It can also be employed to treat postmenopausal women and those receiving tamoxifen treatment as well as advanced directives."
Answered by AI
How many participants is this research endeavor encompassing?
"Indeed, the records on clinicaltrials.gov report that this research project is actively recruiting participants. The trial was made available to public view on May 30th 2019 and has been updated as recently October 25th 2021. So far, 60 patients are needed from a single medical site for inclusion in the study."
Answered by AI
Has the FDA sanctioned Ipatasertib for use?
"The safety profile of Ipatasertib was rated a 1 due to the limited clinical evidence available. As this is a phase 1 trial, there is only preliminary data supporting both its efficacy and safety."
Answered by AI
What other investigations have been executed regarding Ipatasertib?
"At present, 357 clinical trials for Ipatasertib are underway with 71 in the final phase of testing. Shanghai is a major hub for these tests with 19871 locations running experiments on this medication."
Answered by AI
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