Breast Cancer

Verified discoveries, trials, and approvals for this cancer type. Every story separates evidence strength, regulatory status, and guideline position.

Latest Discoveries

Trial Watch: Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic

Research type: Registered later-phase trialRegulatory status: Investigational
Cancer type
Breast Cancer
Published
October 23, 2026

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Primary source cited

Last reviewed

Trial Watch: Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy

Research type: Registered later-phase trialRegulatory status: Investigational
Cancer type
Breast Cancer
Published
October 19, 2026

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Primary source cited

Last reviewed

Trial Watch: Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

Research type: Registered later-phase trialRegulatory status: Investigational
Cancer type
Breast Cancer
Published
October 9, 2026

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Primary source cited

Last reviewed

Trial Watch: A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

Research type: Registered later-phase trialRegulatory status: Investigational
Cancer type
Breast Cancer
Published
October 6, 2026

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Primary source cited

Last reviewed

Trial Watch: A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

Research type: Registered later-phase trialRegulatory status: Investigational
Cancer type
Breast Cancer
Published
September 23, 2026

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Primary source cited

Last reviewed

Major Advances

Investigational triple-negative breast cancer vaccine shows safety and immune response in phase 1 trial

Research type: Early studies in peopleRegulatory status: Investigational
Cancer type
Breast Cancer
Published
August 13, 2026

An investigational alpha-lactalbumin-targeted vaccine, developed by Anixa Biosciences with Cleveland Clinic, was reported to be safe and to induce a protocol-defined immune response in 74% of participants across all three…

Primary source cited

Last reviewed

Six-year OlympiA data sustain the adjuvant olaparib survival benefit in BRCA-mutated, HER2-negative early breast cancer

Research type: High-Certainty EvidenceRegulatory status: FDA Approved
Cancer type
Breast Cancer
Published
August 13, 2026

In the randomized, double-blind, placebo-controlled OlympiA trial, one year of adjuvant olaparib significantly improved invasive disease-free survival (primary publication) and, in a later analysis, significantly improved overall survival as well…

Primary source cited

Last reviewed

FDA expands Enhertu use to HR-positive HER2-low and HER2-ultralow metastatic breast cancer

Research type: Later-stage studies in peopleRegulatory status: FDA Approved
Cancer type
Breast Cancer
Published
August 13, 2026

A specific expanded FDA approval exists for trastuzumab deruxtecan in a defined HR-positive, HER2-low/ultralow metastatic breast cancer population after endocrine therapy, based on a significant progression-free-survival benefit in DESTINY-Breast06.

Primary source cited

Last reviewed

Clinical Trials

Important: Eligibility and enrollment are not guaranteed, and listing here is not a treatment recommendation. Talk to your care team.

Trial Watch: A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)

Regulatory status: InvestigationalResearch type: Registered later-phase trial
Cancer type
Breast Cancer
Trial identifier
NCT07060807
Trial phase
Phase 3
View trial details
Study design
Not specified in this summary
Population
Participants age 18 Years and older with Breast Neoplasms who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-24

Regulatory status by jurisdiction

Country or region not specified

Status
Investigational
Last verified
2026-10-24

Cancer-type scope for this record is not yet recorded.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer

Regulatory status: InvestigationalResearch type: Registered later-phase trial
Cancer type
Breast Cancer
Trial identifier
NCT01674140
Trial phase
Phase 3
View trial details
Study design
Not specified in this summary
Population
Participants age 18 Years and older with Breast Cancer who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-24

Regulatory status by jurisdiction

Country or region not specified

Status
Investigational
Last verified
2026-10-24

Cancer-type scope for this record is not yet recorded.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic

Regulatory status: InvestigationalResearch type: Registered later-phase trial
Cancer type
Breast Cancer
Trial identifier
NCT02115282
Trial phase
Phase 3
View trial details
Study design
Not specified in this summary
Population
Participants age 18 Years and older with Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, HER2/Neu Negative who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-23

Regulatory status by jurisdiction

Country or region not specified

Status
Investigational
Last verified
2026-10-23

Cancer-type scope for this record is not yet recorded.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy

Regulatory status: InvestigationalResearch type: Registered later-phase trial
Cancer type
Breast Cancer
Trial identifier
NCT06763328
Trial phase
Phase 3
View trial details
Study design
Not specified in this summary
Population
Participants age 18 Years and older with Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Invasive Breast Carcinoma who meet the study-specific registry eligibility criteria; sex eligibility: female.
Last reviewed
2026-10-19

Regulatory status by jurisdiction

Country or region not specified

Status
Investigational
Last verified
2026-10-19

Cancer-type scope for this record is not yet recorded.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

Regulatory status: InvestigationalResearch type: Registered later-phase trial
Cancer type
Breast Cancer
Trial identifier
NCT06757634
Trial phase
Phase 3
View trial details
Study design
Not specified in this summary
Population
Participants age 18 Years and older with Breast Cancer who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-09

Regulatory status by jurisdiction

Country or region not specified

Status
Investigational
Last verified
2026-10-09

Cancer-type scope for this record is not yet recorded.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Regulatory status: InvestigationalResearch type: Registered later-phase trial
Cancer type
Breast Cancer
Trial identifier
NCT06966700
Trial phase
Phase 3
View trial details
Study design
Not specified in this summary
Population
Participants age 18 Years and older with Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-06

Regulatory status by jurisdiction

Country or region not specified

Status
Investigational
Last verified
2026-10-06

Cancer-type scope for this record is not yet recorded.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

FDA Approvals

Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.

Six-year OlympiA data sustain the adjuvant olaparib survival benefit in BRCA-mutated, HER2-negative early breast cancer

Regulatory status: FDA ApprovedResearch type: High-Certainty Evidence
Cancer type
Breast Cancer
Population
Adults with germline BRCA1- or BRCA2-mutated, HER2-negative, high-risk early breast cancer, following completion of local treatment and (neo)adjuvant chemotherapy, randomized to one year of adjuvant olaparib or placebo.
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
Adults with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.
Biomarker requirement
Germline BRCA1 or BRCA2 mutation
Decision date
2022-03-11

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

FDA expands Enhertu use to HR-positive HER2-low and HER2-ultralow metastatic breast cancer

Regulatory status: FDA ApprovedResearch type: Later-stage studies in people
Cancer type
Breast Cancer
Population
HR-positive, HER2-low or HER2-ultralow, unresectable or metastatic breast cancer, after progression on endocrine therapy — this exact scope must not be broadened.
View approval details
Last reviewed
2026-08-11

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
HR-positive, HER2-low or HER2-ultralow unresectable/metastatic breast cancer that progressed on one or more endocrine therapies in the metastatic setting.
Biomarker requirement
HER2-low or HER2-ultralow
Decision date
2025-01-27

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-11

Primary evidence supporting this story

Applies to the exact indication stated.

FDA approves inavolisib combination for PIK3CA-mutated, endocrine-resistant HR-positive breast cancer

Regulatory status: FDA ApprovedResearch type: Later-stage studies in people
Cancer type
Breast Cancer
Population
Adults with endocrine-resistant, PIK3CA-mutated (as detected by an FDA-approved test), HR-positive, HER2-negative, locally advanced or metastatic breast cancer, whose disease recurred during or within 12 months of completing adjuvant endocrine therapy (or while still on adjuvant endocrine therapy after at least 2 years), with no prior systemic therapy for metastatic disease — used in combination with palbociclib and fulvestrant, never as a standalone drug.
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
Adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy, in combination with palbociclib and fulvestrant.
Biomarker requirement
PIK3CA mutation
Decision date
2024-10-10

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

Biomarkers & Precision Medicine

Six-year OlympiA data sustain the adjuvant olaparib survival benefit in BRCA-mutated, HER2-negative early breast cancer

Research type: High-Certainty EvidenceRegulatory status: FDA Approved
Cancer type
Breast Cancer
Published
August 13, 2026

In the randomized, double-blind, placebo-controlled OlympiA trial, one year of adjuvant olaparib significantly improved invasive disease-free survival (primary publication) and, in a later analysis, significantly improved overall survival as well…

Primary source cited

Last reviewed

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Related resources

Trusted resources: official cancer information

CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.