Cancer awareness months serve to promote early detection, preventive care, and patient education. For clinicians, these observances provide structured opportunities to emphasize the importance of evidence-based screening protocols and to stay current with emerging clinical research. Enhancing patients’ understanding of symptoms, risk factors, and available supportive resources reduces their anxieties, diminishes stigma, and encourages timely intervention, which can ultimately improve clinical outcomes.
Because October is Breast Cancer Awareness Month, we are featuring five recently initiated Phase 3 clinical trials for breast cancer that are currently recruiting in the United States. Participation in these trials may optimize patient management and support improved clinical outcomes. Clinicians are encouraged to discuss such opportunities with eligible patients as part of a comprehensive care strategy.
Quick View Comparison of the Newest, Currently Recruiting Breast Cancer Clinical Trials
| Study Title | Phase | Estimated Enrollment | Start Date | Estimated Primary Completion |
|---|---|---|---|---|
| Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-02) | 3 | 1000 | 10/31/2025, estimated | December 2028 |
| A Study of LY4064809 With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) | 3 | 920 | October 2025, estimated | May 2029 |
| A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer (TB06) | 3 | 100 | 9/30/2025 | 2/2/2028 |
| A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment | 3 | 400 | 08/05/2025 | 7/22/2027 |
| A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) | 3 | 1000 | 7/21/2025 | 7/14/2033 |
Rundown of the Newest, Currently Recruiting Breast Cancer Clinical Trials
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-02)
- Sponsor: Olema Pharmaceuticals
- Goal: This Phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
- Interventions: Palazestrant, palazestrant-matching placebo, letrozole, letrozole-matching placebo, ribociclib
- Primary Outcome Measure: Progression-free survival.
- Timeframe: From date of randomisation until disease progression or death due to any cause (estimated as up to 3.5 years).
- Study Details
- Source
A Study of LY4064809 With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
- Sponsor: Eli Lilly and Company
- Goal: The purpose of the study is to assess the efficacy and safety of the addition of LY4064809 to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
- Interventions: LY4064809, placebo, ribociclib, palbociclib, abemaciclib, anastrozole, letrozole, exemestane, fulvestrant
- Primary Outcome Measures: (Part 1): Overall response rate: Percentage of participants with confirmed complete response or partial response; (Part 2): Progression-free survival.
- Timeframes: Baseline through disease progression or death (estimated up to five years); Baseline to objective progression or death due to any cause (estimated up to five years).
- Study Details
- Source
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer (TB06)
- Sponsor: AstraZeneca
- Goal: A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.
- Intervention: Dato-DXd
- Primary Outcome Measure: Progression-free survival per RECIST 1.1 as assessed by the investigator.
- Timeframe: From date of first dose of study intervention until disease progression per RECIST 1.1 or death from any cause, whichever occurs first, assessed up to approximately 24 months.
- Study Details
- Source
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment
- Sponsor: Pfizer
- Goal: The purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer.
- Intervention: PF-07248144, fulvestrant, everolimus, exemestane
- Primary Outcome Measure: Progression-free survival as determined by blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Timeframe: From the date of randomization until disease progression or death due to any cause (up to approximately 2 years).
- Study Details
- Source
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
- Sponsor: Merck Sharp & Dohme
- Goal: The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.
- Interventions: Patritumab deruxtecan, paclitaxel, nab-paclitaxel, capecitabine, liposomal doxorubicin, trastuzumab deruxtecan
- Primary Outcome Measures: Progression-free survival; Overall survival.
- Timeframe: Up to approximately 45 months; Up to approximately 85 months.
- Study Details
- Source
Related Guidelines:
Early and Locally Advanced Breast Cancer: Diagnosis and Management
- National Institute for Health and Care Excellence (NICE)
- Last updated: April 14, 2025
Advanced Breast Cancer: Diagnosis and Treatment
- National Institute for Health and Care Excellence (NICE)
- Latest update: February 19, 2025
Systemic Treatment of Patients with Metastatic Breast Cancer
- American Society of Clinical Oncology (ASCO)
- Date published: January 10, 2024
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