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 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

Evidence stage: Later-Stage HumanRegulatory status: Investigational
Cancer type
Breast Cancer
Published
August 14, 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

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.

Trial Watch: 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

Regulatory status: InvestigationalEvidence stage: Later-Stage Human
Cancer type
Breast Cancer
Trial identifier
NCT07391774
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 IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma who meet the study-specific registry eligibility criteria.
Last reviewed
2026-08-14

Regulatory status by jurisdiction

Unspecified jurisdiction

Status
Investigational
Last verified
2026-08-14

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.

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.