Breast CancerPhase 2NCT05101564

Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer

A Phase 2 study testing Alpelisib, Tamoxifen and Zotatifin in people with Breast Cancer and HER2-negative Breast Cancer, run by Jennifer Lee Caswell-Jin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to learn if adding a new drug that is targeted at a specific genetic change found in some breast tumors pre-operatively will slow the growth of the tumor more than standard anti-hormone therapy used to treat this type of breast cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer
What is being tested?: Alpelisib, Tamoxifen and Zotatifin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 20 Mar 2023to 3 Jun 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Pre-Screening Phase
Biopsy-proven ER-positive, HER2-negative breast cancer. ER-positivity and PR-positivity are defined as ≥1% cells staining positive by immunohistochemistry. HER2-negativity is defined by IHC or FISH, per ASCO-CAP 2018 guidelines. Breast tumor must be intact and tumor size must be ≥ 1 cm as measured by ultrasound, mammogram, MRI, or clinical exam. If tumor is locally recurrent, it must be in the breast (not skin, node, or chest wall recurrence). Ki67 may or may not have been done locally but if done locally, must be ≥ 5%. Any nodal status is allowed, as M0 or M1 disease.
Women or men, age ≥ 18 years old.
Performance status 0 to 1 (by Eastern Cooperative Oncology Group [ECOG] scale).
Ability to understand and the willingness to sign a written informed consent document.
Treatment Phase

Show all 9Show fewer

Breast tumor classifies as relevant integrative subtype per tumor sequencing performed and analyzed by central laboratory.
Breast tumor Ki67 score ≥ 10% as assessed by central laboratory.
Each investigational agent specific inclusion criteria can be found in the agent-specific appendix

Who cannot join

Pregnant woman, as confirmed by positive serum hCG test prior to initiating study treatment. Nursing (lactating) woman also not allowed.
Prior breast cancer-directed therapy (surgery, radiation, chemotherapy, or endocrine therapy) is not allowed, with the exception of people with in-breast recurrences. People with in-breast recurrences cannot have had breast cancer-directed therapy (radiation, chemotherapy, or endocrine therapy; surgery is acceptable) within the 6 months prior to signing the pre-screening consent. Pre-endocrine therapy for breast cancer risk reduction is allowed.
Known hypersensitivity to study agent (IP) or standard endocrine therapy drug, or to any of the excipients of study agent (IP) or standard endocrine therapy drug.
Each study agent specific exclusion criteria can be found in the agent-specific appendix

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94304

Other trials in United States

About this study

Official title: An Umbrella, Randomized, Controlled, Pre Operative Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer

Read the detailed description

Primary Objective: To evaluate the efficacy of investigational agent compared with standard endocrine therapy in in reducing Ki67 values based on digital pathology (QuPath) from baseline to on-treatment biopsy after an specific treatment duration (i.e. 14 days) in ER-positive, HER2-negative tumors (tumor size ≥1 cm) with Ki67 ≥ 10%, for different integrative subtype categories identified at integrative subtype screening.

Secondary Objective: To evaluate the efficacy of investigational agent compared with standard endocrine therapy on the proportion of subjects with Ki67 < 10% after a specific treatment duration (i.e. 14 days)

Conditions: Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer
Being tested: Alpelisib, Tamoxifen, Zotatifin, Fulvestrant
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlpelisibDrug
Also called Piqray, BYL719
Alpelisib 300 mg
TamoxifenDrug
Also called Soltamox, TAM
Tamoxifen 20 mg
ZotatifinDrug
Also called eFT226
Zotatifin 0.10mg/kg (by weight)
FulvestrantDrug
Also called Faslodex
Fulvestrant 500 mg

Study groups in NCT05101564
Study group	Role	What they receive
IC1:Alpelisib in combination with Tamoxifen (closed to enrollment)	Experimental	Integrative subtype IC1, Treatment (14 days, - 2 or + 7 days): Take assigned alpelisib pills, 300 mg (two 150 mg tablets) with food, once daily by mouth. Tamoxifen pills, 20 mg once daily by mouth Receives: Drug: Alpelisib; Drug: Tamoxifen
IC1:Tamoxifen (closed to enrollment)	Active comparator	Integrative subtype 1, Treatment (14 days, -2 to +7 days): Take assigned tamoxifen pills, 20 mg once daily by mouth Receives: Drug: Tamoxifen
IC2:Zotatifin in combination with Fulvestrant	Experimental	Integrative subtype 2, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. Receives: Drug: Zotatifin; Drug: Fulvestrant
IC2:Fulvestrant	Active comparator	Integrative subtype 2, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. Receives: Drug: Fulvestrant
IC3:Zotatifin in combination with Fulvestrant	Experimental	Integrative subtype 3, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. Receives: Drug: Zotatifin; Drug: Fulvestrant
IC3:Fulvestrant	Active comparator	Integrative subtype 3, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. on Day 1. Receives: Drug: Fulvestrant
IC4:Zotatifin in combination with Fulvestrant	Experimental	Integrative subtype 4, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. Receives: Drug: Zotatifin; Drug: Fulvestrant
IC4:Fulvestrant	Active comparator	Integrative subtype 4, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.. Receives: Drug: Fulvestrant
IC6:Zotatifin in combination with Fulvestrant	Experimental	Integrative subtype 6, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. Receives: Drug: Zotatifin; Drug: Fulvestrant
IC6:Fulvestrant	Active comparator	Integrative subtype 6, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. Receives: Drug: Fulvestrant
IC7:Zotatifin in combination with Fulvestrant	Experimental	Integrative subtype 7, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. Receives: Drug: Zotatifin; Drug: Fulvestrant
IC7:Fulvestrant	Active comparator	Integrative subtype 7, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. Receives: Drug: Fulvestrant
IC8:Zotatifin in combination with Fulvestrant	Experimental	Integrative subtype 8, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. Receives: Drug: Zotatifin; Drug: Fulvestrant
IC8:Fulvestrant	Active comparator	Integrative subtype 8, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. Receives: Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change in Ki67
The primary outcome is the percentage change in Ki67 expression comparing pre-treatment to on-treatment specimens. Ki67 values were log-transformed for analysis, and results are summarized as the mean percentage change with 95% confidence intervals.
Measured: Measured pre-treatment and after treatment 15 or 19 days, based on the duration specified for the assigned therapy

Secondary outcomes (1)

Ki67 <10% On-treatment Measurement
The proportions of subjects with Ki67 less than 10% after treatment. The outcome will be reported as a number without dispersion.
Measured: 15 or 19 days, based on the duration specified for the assigned therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 20233 Jun 2024

First posted1 Nov 2021
Study start20 Mar 2023
Primary completion3 Jun 2024
Study completion3 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05101564
Sponsor's protocol ID: IRB-52869
Other IDs: NCI-2023-02578
Status last verified: Jan 2026
First submitted: 28 Oct 2021
Last updated: 12 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Umbrella, Randomized, Controlled, Pre Operative Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer
ClinicalTrials.gov ID: NCT05101564
Acronym / sponsor ID: IRB-52869
Conditions: Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Jennifer Lee Caswell-JinUniversity, hospital or other
Collaborators: United States Department of Defense, Novartis Pharmaceuticals, Effector Therapeutics
Study start: 20 Mar 2023 (actual)
Primary completion: 3 Jun 2024 (actual)
Study completion: 3 Jun 2024 (actual)
First posted: 1 Nov 2021 (actual)
Results: Posted 22 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 14

Arm	Type	Receives
IC1:Alpelisib in combination with Tamoxifen (closed to enrollment)	Experimental	Drug: Alpelisib, Drug: TamoxifenIntegrative subtype IC1, Treatment (14 days, - 2 or + 7 days): Take assigned alpelisib pills, 300 mg (two 150 mg tablets) with food, once daily by mouth. Tamoxifen pills, 20 mg once daily by mouth
IC1:Tamoxifen (closed to enrollment)	Active comparator	Drug: TamoxifenIntegrative subtype 1, Treatment (14 days, -2 to +7 days): Take assigned tamoxifen pills, 20 mg once daily by mouth
IC2:Zotatifin in combination with Fulvestrant	Experimental	Drug: Zotatifin, Drug: FulvestrantIntegrative subtype 2, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
IC2:Fulvestrant	Active comparator	Drug: FulvestrantIntegrative subtype 2, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
IC3:Zotatifin in combination with Fulvestrant	Experimental	Drug: Zotatifin, Drug: FulvestrantIntegrative subtype 3, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
IC3:Fulvestrant	Active comparator	Drug: FulvestrantIntegrative subtype 3, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1. on Day 1.
IC4:Zotatifin in combination with Fulvestrant	Experimental	Drug: Zotatifin, Drug: FulvestrantIntegrative subtype 4, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
IC4:Fulvestrant	Active comparator	Drug: FulvestrantIntegrative subtype 4, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1..
IC6:Zotatifin in combination with Fulvestrant	Experimental	Drug: Zotatifin, Drug: FulvestrantIntegrative subtype 6, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
IC6:Fulvestrant	Active comparator	Drug: FulvestrantIntegrative subtype 6, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
IC7:Zotatifin in combination with Fulvestrant	Experimental	Drug: Zotatifin, Drug: FulvestrantIntegrative subtype 7, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
IC7:Fulvestrant	Active comparator	Drug: FulvestrantIntegrative subtype 7, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
IC8:Zotatifin in combination with Fulvestrant	Experimental	Drug: Zotatifin, Drug: FulvestrantIntegrative subtype 8, Treatment (14 days, - 2 to +7 days). Zotatifin (calculated by weight, 0.10 mg/kg) should be administered as a 60-minute IV infusion on Days 1. A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.
IC8:Fulvestrant	Active comparator	Drug: FulvestrantIntegrative subtype 8, Treatment (14 days, - 2 to +7 days) A total of 500 mg Fulvestrant should be administered intramuscularly as two 5mL injection on Day 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Pre-Screening Phase
Biopsy-proven ER-positive, HER2-negative breast cancer. ER-positivity and PR-positivity are defined as ≥1% cells staining positive by immunohistochemistry. HER2-negativity is defined by IHC or FISH, per ASCO-CAP 2018 guidelines. Breast tumor must be intact and tumor size must be ≥ 1 cm as measured by ultrasound, mammogram, MRI, or clinical exam. If tumor is locally recurrent, it must be in the breast (not skin, node, or chest wall recurrence). Ki67 may or may not have been done locally but if done locally, must be ≥ 5%. Any nodal status is allowed, as M0 or M1 disease.
Women or men, age ≥ 18 years old.
Performance status 0 to 1 (by Eastern Cooperative Oncology Group [ECOG] scale).
Ability to understand and the willingness to sign a written informed consent document.

Key exclusion criteria (4 listed)

Pregnant woman, as confirmed by positive serum hCG test prior to initiating study treatment. Nursing (lactating) woman also not allowed.
Prior breast cancer-directed therapy (surgery, radiation, chemotherapy, or endocrine therapy) is not allowed, with the exception of people with in-breast recurrences. People with in-breast recurrences cannot have had breast cancer-directed therapy (radiation, chemotherapy, or endocrine therapy; surgery is acceptable) within the 6 months prior to signing the pre-screening consent. Pre-endocrine therapy for breast cancer risk reduction is allowed.
Known hypersensitivity to study agent (IP) or standard endocrine therapy drug, or to any of the excipients of study agent (IP) or standard endocrine therapy drug.
Each study agent specific exclusion criteria can be found in the agent-specific appendix

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
AlpelisibAlso: Piqray, BYL719Alpelisib 300 mg	Drug	IC1:Alpelisib in combination with Tamoxifen (closed to enrollment)
TamoxifenAlso: Soltamox, TAMTamoxifen 20 mg	Drug	IC1:Alpelisib in combination with Tamoxifen (closed to enrollment), IC1:Tamoxifen (closed to enrollment)
ZotatifinAlso: eFT226Zotatifin 0.10mg/kg (by weight)	Drug	IC2:Zotatifin in combination with Fulvestrant, IC3:Zotatifin in combination with Fulvestrant, IC4:Zotatifin in combination with Fulvestrant, IC6:Zotatifin in combination with Fulvestrant, IC7:Zotatifin in combination with Fulvestrant, IC8:Zotatifin in combination with Fulvestrant
FulvestrantAlso: FaslodexFulvestrant 500 mg	Drug	IC2:Fulvestrant, IC2:Zotatifin in combination with Fulvestrant, IC3:Fulvestrant, IC3:Zotatifin in combination with Fulvestrant, IC4:Fulvestrant, IC4:Zotatifin in combination with Fulvestrant, IC6:Fulvestrant, IC6:Zotatifin in combination with Fulvestrant, IC7:Fulvestrant, IC7:Zotatifin in combination with Fulvestrant, IC8:Fulvestrant, IC8:Zotatifin in combination with Fulvestrant

Primary outcome

Percentage Change in Ki67
Time frame: Measured pre-treatment and after treatment 15 or 19 days, based on the duration specified for the assigned therapy
The primary outcome is the percentage change in Ki67 expression comparing pre-treatment to on-treatment specimens. Ki67 values were log-transformed for analysis, and results are summarized as the mean percentage change with 95% confidence intervals.

1 secondary outcome

Ki67 <10% On-treatment Measurement
Time frame: 15 or 19 days, based on the duration specified for the assigned therapy

Results and safety

Results posted to the registry on 22 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 2: Zotatifin in Combination With Fulvestrant (Treatment Arm)	2	2
Cohort 2: Fulvestrant (Control Arm)	2	2
Cohort 3:Zotatifin in Combination With Fulvestrant (Treatment Arm)	7	6
Cohort 3:Fulvestrant (Control Arm)	8	8

Primary outcome: Percentage Change in Ki67

Time frame: Measured pre-treatment and after treatment 15 or 19 days, based on the duration specified for the assigned therapy. Mean (95% Confidence Interval). Unit: percentage

Measure	Cohort 2: Zotatifin in Combination With Fulvestrant (Treatment Arm) n = 2	Cohort 2: Fulvestrant (Control Arm) n = 2	Cohort 3: Zotatifin in Combination With Fulvestrant (Treatment Arm) n = 6	Cohort 3: Fulvestrant (Control Arm) n = 8
Value	-0.64 (-4.28 to 2.99)	-0.68 (-3.99 to 2.64)	-0.63 (-0.92 to -0.34)	-0.46 (-0.75 to -0.17)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 2: Zotatifin in Combination With Fulvestrant (Treatment Arm)	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cohort 2: Fulvestrant (Control Arm)	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cohort 3:Zotatifin in Combination With Fulvestrant (Treatment Arm)	0 of 7 (0%)	7 of 7 (100%)	0 of 7
Cohort 3: Fulvestrant (Control Arm)	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Jennifer Caswell-Jin principal investigator

Stanford Universiy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alpelisib, Tamoxifen and Zotatifin in people with Breast Cancer and HER2-negative Breast Cancer, run by Jennifer Lee Caswell-Jin 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 9 inclusion and 4 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: finished, as of the sponsor's last update on 12 Feb 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage Change in Ki67 (time frame: Measured pre-treatment and after treatment 15 or 19 days, based on the duration specified for the assigned therapy). 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 NCT05101564.

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 12 Feb 2026.