Breast CancerPhase 1NCT03959891
AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor for Patients With Metastatic Breast Cancer (TAKTIC)
A Phase 1 study testing Ipatasertib, Fulvestrant and Aromatase Inhibitor in people with Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is exploring the safety/tolerabtility and preliminary efficacy of the combination of Ipatasertib with Aromatase inhibitor or Fulvestrant for patients with metastatic HR+ breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ipatasertib, Fulvestrant and Aromatase Inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2019to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women (≥ 18 years of age) with biopsy proven HR+/HER2 negative breast cancer; HR+ defined as ≥1% positivity for ER, and/or PR (≥1%), as per local assessment. HER2 as per standard CAP guidelines (local assessment).
- Postmenopausal women with locally advanced or metastatic BC. Patients must be postmenopausal women as defined by one of the following:
- Women >60 years OR
- Women ≤60 years, and any one of following:
- LH and FSH level in the postmenopausal range according to institutional standards
- s/p post bilateral surgical oophorectomy.
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- Premenopausal/perimenopausal women on gonadotropin-releasing hormone agonist (to be continued during study) and estradiol level in the postmenopausal range according to institutional standards
- Disease progression on at least one prior therapy for metastatic disease, including endocrine therapy with/without CDK 4/6 inhibitor (palbociclib or ribociclib or abemaciclib). Disease recurrence during/within 12 month of (neo)adjuvant endocrine therapy (with/without CDK 4/6 inhibitor) will count as one prior therapy for this definition.
- ECOG Performance Status 0 - 2
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Evaluable or measurable disease: at least one lesion that can be accurately measured in at least one dimension ≥ 20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI. Bone lesions in the absence of measurable disease as defined above is also acceptable.
- Discontinuation of prior breast cancer therapies, including endocrine therapy, for 14 days (non-myelosuppressive) or 21 days (myelosuppressive). Wash-out for Fulvestrant and tamoxifen will be 28 days.
- Prior mTOR inhibitor and/or PI3K inhibitor allowed (all arms)
- Prior aromatase inhibitor is allowed (all arms)
- Adequate bone marrow function: ANC ≥ 1000/mm3, hemoglobin ≥9 g/dl, and platelets ≥ 100,000/mm3.
- Adequate hepatic function: Total bilirubin < 1.5mg/dL, AST and ALT < 3X Institutional ULN (or 5 X Institutional ULN in presence of hepatic mets).
- Adequate renal function: Calculated creatinine clearance ≥ 30 mL/min
- Fasting blood glucose <140 mg/dL, and hemoglobin A1c <7.
- Signed informed consent and agree to comply with study procedures.
Who cannot join
- Participants with progressive CNS metastatic disease. Patients with stable CNS metastasis would be eligible, provided mets radiologically stable for atleast one month, and patient is not actively taking steroids.
- Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Prior use of AKT inhibitor (any setting)
- Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., inflammatory bowel disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including any of the following:
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- History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study entry.
- Documented cardiomyopathy.
- History of cardiac failure, significant/symptomatic bradycardia, Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following:
- Known risk to prolong the QT interval or induce Torsade's de Pointes.
- Uncorrected hypomagnesemia or hypokalemia.
- Systolic Blood Pressure (SBP) >160 mmHg or <90 mmHg.
- Bradycardia (heart rate <50 at rest), by ECG or pulse.
- On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF >450 screening ECG (based on a mean of 3 ECGs).
- HIV-positive participants on combination antiretroviral therapy are ineligible. These participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
- History of Type I or Type II diabetes mellitus requiring insulin. Patients who are on a stable dose of oral diabetes medication ≥ 2 weeks prior to initiation of study treatment are eligible for enrollment. Patients must meet the laboratory eligibility criteria for fasting blood glucose and hemoglobin A1c as outlined in the inclusion criteria.
- Pregnant women are excluded from this study because the safety of study medications is not established in pregnant women.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of bilateral oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. Highly effective contraception methods include:
- Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
- Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
- In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Note: While oral contraceptives are allowed, they should be used in conjunction with a barrier method of contraception due to unknown effect of drug-drug interaction.
- For Arm A only: patients who have received prior fulvestrant.
- For Arm C only: h/o of intolerable toxicity to CDK 4/6 inhibitor resulting in treatment discontinuation due to toxicity
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02115
About this study
Official title: Clinical Trial to Evaluate Safety and Anti-tumor Activity of AKT Inhibitor, Ipatasertib,With Endocrine Therapy With/Without CDK 4/6 Inhibitor for Patients With Metastatic Hormone Receptor Positive Breast Cancer (TAKTIC)
This study is exploring the safety/tolerabtility and preliminary efficacy of the combination of Ipatasertib with Aromatase inhibitor or Fulvestrant for patients with metastatic HR+ breast cancer.
Read the detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved ipatasertib as a treatment for any disease.
The FDA has approved fulvestrant, the aromatase inhibitors, and palbociclib as treatment options for this disease.
This research study will evaluate the safety and tolerability of ipatasertib in combination with an aromatase inhibitor or fulvestrant with or without palbociclib.
Resistance to standard of care treatment for people with your type of cancer is common. Stopping (inhibiting) an enzyme called Akt in the cancer cells may overcome resistance to the standard of care treatment. Ipatasertib is a type of inhibitor that is believed to work by inhibiting Akt. Through the different combinations of ipatasertib and the standard of care drugs, the chance of cancer cells becoming resistant to the standard of care drugs may decrease, causing the cancer cells to stop growing and spreading.
- Conditions
- Breast Cancer
- Being tested
- Ipatasertib, Fulvestrant, Aromatase Inhibitor, Palbociclib
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpatasertibDrug
Also called GDC-0068
Ipatasertib is a type of inhibitor that is believed to work by inhibiting Akt.
FulvestrantDrug
Also called Falsodex
Hormone therapies work by stopping the production of a certain hormone, blocking hormone receptors, or substituting chemically similar agents for the active hormone, which cannot be used by the tumor cell.
Aromatase InhibitorDrug
Also called Letrozole
Letrozole is an aromatase inhibitor. This means it blocks the enzyme aromatase (found in the body's muscle, skin, breast and fat), which is used to convert androgens (hormones produced by the adrenal glands) into estrogen. In the absence of estrogen, tumors dependent on this hormone for growth will shrink.
PalbociclibDrug
Also called Ibrance
Palbociclib (Ibrance®) is a drug that can be used along with an aromatase inhibitor to treat women with advanced hormone receptor-positive breast cancer. Palbociclib is a reversible small molecule cyclin-dependent kinase (CDK) inhibitor. The drug blocks proteins in the cell called cyclin-dependent kinase (CDK) 4 and CDK 6. In hormone positive breast cancer cells, blocking these proteins helps stop the cells from dividing to make new cells. It helps prevent the cells from moving from G1 to S cell cycle phase in the division process. This slows cancer growth.
| Study group | Role | What they receive |
|---|---|---|
| Fulvestrant + Ipatasertib | Experimental | * 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. Receives: Drug: Ipatasertib; Drug: Fulvestrant |
| Aromatase Inhibitor + Ipatasertib | Experimental | * Ipatasertib will be administered orally on a daily basis
* Aromatase inhibitors will be administered orally on a daily basis Receives: Drug: Ipatasertib; Drug: Aromatase Inhibitor |
| Fulvestrant + Ipatasertib +Palbociclib | Experimental | * 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 Receives: Drug: Ipatasertib; Drug: Fulvestrant; Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
grade 1-5 (CTCAE)
Measured: 2 years
Secondary outcomes (5)
Progression Free Survival
Kaplan-Meier Analysis
Measured: 2 years
Overall Response Rate
RECIST criteria
Measured: 2 years
Complete Response
RECIST criteria
Measured: 2 Years
Partial Response
RECIST criteria
Measured: 2 years
Overall Survival
Kaplan-Meier Analysis
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start30 May 2019
- Primary completion25 Dec 2022
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Seth A. Wander, M.D., Ph.D., Massachusetts General Hospital
- Investigators
- Seth Wander, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959891
- Sponsor's protocol ID
- 19-086
- Status last verified
- Aug 2026
- First submitted
- 15 May 2019
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Wander SA, Lloyd MR, Keenan JC, Scott EC, Niemierko A, Spring LM, Fell GG, Shin J, Isakoff SJ, Moy B, Ryan L, Padden S, Fisher E, Newton A, Habin KR, Viscosi-Spieler ET, Scarpetti L, Varkaris A, Ellisen LW, Dubash T, Che D, Patel PS, de la Cruz FF, Sutaria DS, Sane RS, Micalizzi DS, Maheswaran S, Haber DA, Juric D, Bardia A. Safety and antitumour activity of ipatasertib combined with endocrine therapy and a CDK4/6 inhibitor in HR+/HER2- metastatic breast cancer (TAKTIC): a single-centre, open-label, phase 1b trial. Lancet Oncol. 2026 May;27(5):580-591. doi: 10.1016/S1470-2045(26)00059-8.
PubMed 42061370
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate Safety and Anti-tumor Activity of AKT Inhibitor, Ipatasertib,With Endocrine Therapy With/Without CDK 4/6 Inhibitor for Patients With Metastatic Hormone Receptor Positive Breast Cancer (TAKTIC)
- ClinicalTrials.gov ID
- NCT03959891
- Acronym / sponsor ID
- 19-086
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 30 May 2019 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is exploring the safety/tolerabtility and preliminary efficacy of the combination of Ipatasertib with Aromatase inhibitor or Fulvestrant for patients with metastatic HR+ breast cancer.
Detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved ipatasertib as a treatment for any disease.
The FDA has approved fulvestrant, the aromatase inhibitors, and palbociclib as treatment options for this disease.
This research study will evaluate the safety and tolerability of ipatasertib in combination with an aromatase inhibitor or fulvestrant with or without palbociclib.
Resistance to standard of care treatment for people with your type of cancer is common. Stopping (inhibiting) an enzyme called Akt in the cancer cells may overcome resistance to the standard of care treatment. Ipatasertib is a type of inhibitor that is believed to work by inhibiting Akt. Through the different combinations of ipatasertib and the standard of care drugs, the chance of cancer cells becoming resistant to the standard of care drugs may decrease, causing the cancer cells to stop growing and spreading.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fulvestrant + Ipatasertib | Experimental | Drug: Ipatasertib, Drug: Fulvestrant* 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. |
| Aromatase Inhibitor + Ipatasertib | Experimental | Drug: Ipatasertib, Drug: Aromatase Inhibitor* Ipatasertib will be administered orally on a daily basis * Aromatase inhibitors will be administered orally on a daily basis |
| Fulvestrant + Ipatasertib +Palbociclib | Experimental | Drug: Ipatasertib, Drug: Fulvestrant, Drug: Palbociclib* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Adult women (≥ 18 years of age) with biopsy proven HR+/HER2 negative breast cancer; HR+ defined as ≥1% positivity for ER, and/or PR (≥1%), as per local assessment. HER2 as per standard CAP guidelines (local assessment).
- Postmenopausal women with locally advanced or metastatic BC. Patients must be postmenopausal women as defined by one of the following:
- Disease progression on at least one prior therapy for metastatic disease, including endocrine therapy with/without CDK 4/6 inhibitor (palbociclib or ribociclib or abemaciclib). Disease recurrence during/within 12 month of (neo)adjuvant endocrine therapy (with/without CDK 4/6 inhibitor) will count as one prior therapy for this definition.
- ECOG Performance Status 0 - 2
- Left ventricular ejection fraction (LVEF) ≥ 50%
Key exclusion criteria (24 listed)
- Participants with progressive CNS metastatic disease. Patients with stable CNS metastasis would be eligible, provided mets radiologically stable for atleast one month, and patient is not actively taking steroids.
- Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Prior use of AKT inhibitor (any setting)
- Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., inflammatory bowel disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IpatasertibAlso: GDC-0068Ipatasertib is a type of inhibitor that is believed to work by inhibiting Akt. | Drug | Aromatase Inhibitor + Ipatasertib, Fulvestrant + Ipatasertib, Fulvestrant + Ipatasertib +Palbociclib |
| FulvestrantAlso: FalsodexHormone therapies work by stopping the production of a certain hormone, blocking hormone receptors, or substituting chemically similar agents for the active hormone, which cannot be used by the tumor cell. | Drug | Fulvestrant + Ipatasertib, Fulvestrant + Ipatasertib +Palbociclib |
| Aromatase InhibitorAlso: LetrozoleLetrozole is an aromatase inhibitor. This means it blocks the enzyme aromatase (found in the body's muscle, skin, breast and fat), which is used to convert androgens (hormones produced by the adrenal glands) into estrogen. In the absence of estrogen, tumors dependent on this hormone for growth will shrink. | Drug | Aromatase Inhibitor + Ipatasertib |
| PalbociclibAlso: IbrancePalbociclib (Ibrance®) is a drug that can be used along with an aromatase inhibitor to treat women with advanced hormone receptor-positive breast cancer. Palbociclib is a reversible small molecule cyclin-dependent kinase (CDK) inhibitor. The drug blocks proteins in the cell called cyclin-dependent kinase (CDK) 4 and CDK 6. In hormone positive breast cancer cells, blocking these proteins helps stop the cells from dividing to make new cells. It helps prevent the cells from moving from G1 to S cell cycle phase in the division process. This slows cancer growth. | Drug | Fulvestrant + Ipatasertib +Palbociclib |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 2 years
grade 1-5 (CTCAE)
5 secondary outcomes
Progression Free Survival
Time frame: 2 years
Overall Response Rate
Time frame: 2 years
Complete Response
Time frame: 2 Years
Partial Response
Time frame: 2 years
Overall Survival
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 42061370Wander SA, Lloyd MR, Keenan JC, Scott EC, Niemierko A, Spring LM, Fell GG, Shin J, Isakoff SJ, Moy B, Ryan L, Padden S, Fisher E, Newton A, Habin KR, Viscosi-Spieler ET, Scarpetti L, Varkaris A, Ellisen LW, Dubash T, Che D, Patel PS, de la Cruz FF, Sutaria DS, Sane RS, Micalizzi DS, Maheswaran S, Haber DA, Juric D, Bardia A. Safety and antitumour activity of ipatasertib combined with endocrine therapy and a CDK4/6 inhibitor in HR+/HER2- metastatic breast cancer (TAKTIC): a single-centre, open-label, phase 1b trial. Lancet Oncol. 2026 May;27(5):580-591. doi: 10.1016/S1470-2045(26)00059-8.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Wander, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ipatasertib, Fulvestrant and Aromatase Inhibitor in people with Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.