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: Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy

Evidence stage: Later-Stage HumanRegulatory status: Investigational
Cancer type
Breast Cancer
Published
September 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: Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer

Evidence stage: Later-Stage HumanRegulatory status: Investigational
Cancer type
Breast Cancer
Published
September 18, 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 to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment

Evidence stage: Later-Stage HumanRegulatory status: Investigational
Cancer type
Breast Cancer
Published
September 18, 2026

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Not Yet 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 to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Evidence stage: Later-Stage HumanRegulatory status: Investigational
Cancer type
Breast Cancer
Published
September 14, 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: A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Evidence stage: Later-Stage HumanRegulatory status: Investigational
Cancer type
Breast Cancer
Published
September 3, 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

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

Evidence stage: 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

Evidence stage: Later-Stage HumanRegulatory 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 Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

Regulatory status: InvestigationalEvidence stage: Later-Stage Human
Cancer type
Breast Cancer
Trial identifier
NCT04400695
Trial phase
Phase 3
View trial details
Study design
Other / not applicable
Population
Participants ages 18 Years to 70 Years with Breast Cancer who meet the study-specific registry eligibility criteria.
Last reviewed
2026-09-23

Regulatory status by jurisdiction

Unspecified jurisdiction

Status
Investigational
Last verified
2026-09-23

This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy

Regulatory status: InvestigationalEvidence stage: Later-Stage Human
Cancer type
Breast Cancer
Trial identifier
NCT04989504
Trial phase
Phase 3
View trial details
Study design
Other / not applicable
Population
Participants age 18 Years and older with Breast Carcinoma who meet the study-specific registry eligibility criteria.
Last reviewed
2026-09-23

Regulatory status by jurisdiction

Unspecified jurisdiction

Status
Investigational
Last verified
2026-09-23

This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer

Regulatory status: InvestigationalEvidence stage: Later-Stage Human
Cancer type
Breast Cancer
Trial identifier
NCT06058377
Trial phase
Phase 3
View trial details
Study design
Other / not applicable
Population
Participants age 18 Years and older with Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma who meet the study-specific registry eligibility criteria.
Last reviewed
2026-09-18

Regulatory status by jurisdiction

Unspecified jurisdiction

Status
Investigational
Last verified
2026-09-18

This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment

Regulatory status: InvestigationalEvidence stage: Later-Stage Human
Cancer type
Breast Cancer
Trial identifier
NCT07827573
Trial phase
Phase 3
View trial details
Study design
Other / not applicable
Population
Participants age 18 Years and older with Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer who meet the study-specific registry eligibility criteria.
Last reviewed
2026-09-18

Regulatory status by jurisdiction

Unspecified jurisdiction

Status
Investigational
Last verified
2026-09-18

This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Regulatory status: InvestigationalEvidence stage: Later-Stage Human
Cancer type
Breast Cancer
Trial identifier
NCT06065748
Trial phase
Phase 3
View trial details
Study design
Other / not applicable
Population
Participants age 18 Years and older with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer who meet the study-specific registry eligibility criteria.
Last reviewed
2026-09-14

Regulatory status by jurisdiction

Unspecified jurisdiction

Status
Investigational
Last verified
2026-09-14

This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

Regulatory status: InvestigationalEvidence stage: Later-Stage Human
Cancer type
Breast Cancer
Trial identifier
NCT06393374
Trial phase
Phase 3
View trial details
Study design
Other / not applicable
Population
Participants age 18 Years and older with Triple-Negative Breast Cancer who meet the study-specific registry eligibility criteria.
Last reviewed
2026-09-11

Regulatory status by jurisdiction

Unspecified jurisdiction

Status
Investigational
Last verified
2026-09-11

This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.

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 ApprovedEvidence stage: 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 ApprovedEvidence stage: Later-Stage Human
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 ApprovedEvidence stage: Later-Stage Human
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

Evidence stage: 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.