Breast Cancer

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

Latest Discoveries

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

Phase 3 ASCENT-07 trial finds no progression-free-survival benefit for sacituzumab govitecan over chemotherapy in HR-positive breast cancer

Evidence stage: Later-Stage HumanRegulatory status: Investigational
Cancer type
Breast Cancer
Published
August 13, 2026

In the randomized, phase 3 ASCENT-07 trial, sacituzumab govitecan did NOT improve progression-free survival compared with standard-of-care chemotherapy as a first chemotherapy option for hormone-receptor-positive, HER2-negative advanced breast cancer --…

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

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

Evidence stage: Later-Stage HumanRegulatory status: FDA Approved
Cancer type
Breast Cancer
Published
August 13, 2026

In the randomized, double-blind, placebo-controlled INAVO120 trial, adding inavolisib to palbociclib and fulvestrant significantly delayed disease progression compared with palbociclib and fulvestrant alone, in a PIK3CA-mutated, endocrine-resistant, first-line metastatic breast…

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.

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

Regulatory status: InvestigationalEvidence stage: Early Human
Cancer type
Breast Cancer
Trial identifier
NCT04674306
View trial details
Study design
Non-randomized trial
Population
Adults enrolled across three cohorts of a first-in-human phase 1 trial: (1a) triple-negative breast cancer (TNBC) survivors who completed treatment within the prior three years and remain at high recurrence risk; (1b) cancer-free carriers of breast-cancer-associated genetic mutations who elected preventive mastectomy; and (1c) early-stage TNBC patients who received pre-operative chemoimmunotherapy and were subsequently vaccinated in combination with pembrolizumab.
Last reviewed
2026-08-13

Regulatory status by jurisdiction

Unspecified jurisdiction

Status
Investigational
Last verified
2026-08-13

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.

Phase 3 ASCENT-07 trial finds no progression-free-survival benefit for sacituzumab govitecan over chemotherapy in HR-positive breast cancer

Regulatory status: InvestigationalEvidence stage: Later-Stage Human
Cancer type
Breast Cancer
Trial identifier
NCT05840211
View trial details
Study design
Randomized controlled trial
Population
Adults with hormone-receptor-positive, HER2-negative locally advanced, inoperable, or metastatic breast cancer previously treated with endocrine therapy and eligible for first-line chemotherapy, randomized 2:1 to sacituzumab govitecan or standard-of-care chemotherapy, in the randomized, open-label, phase 3 ASCENT-07 trial.
Last reviewed
2026-08-13

Regulatory status by jurisdiction

Unspecified jurisdiction

Status
Investigational
Last verified
2026-08-13

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.