The following clinical trials represent a selection of key studies currently recruiting patients with breast cancer for inclusion in investigations of new therapies and new regimens of existing treatments for the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to one of these clinical trials.

The purpose of this randomized, open-label, phase 3 study is to assess the efficacy and safety of extended therapy with camizestrant (AZD9833), a next-generation oral selective estrogen receptor (ER) antagonist and degrader, versus standard endocrine therapy with an aromatase inhibitor (exemestane [Aromasin], letrozole [Femara], or anastrozole [Arimidex]) or tamoxifen (Soltamox) in patients with ER-positive, HER2-negative, early-stage breast cancer who have completed definitive locoregional therapy and standard endocrine therapy for at least 2 years and up to 5 years. Patients aged ≥18 years with histologically confirmed ER-positive, HER2-negative, early-stage resected invasive breast cancer with high or immediate risk for recurrence; who have completed at least 2 years but no more than 5 years of adjuvant endocrine therapy; and who have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 may be eligible if other criteria are met. Eligible patients will be randomized 1:1 to either continue standard endocrine therapy (investigator’s choice of an aromatase inhibitor or tamoxifen), or to receive oral camizestrant.

The primary outcome measure is invasive breast cancer–free survival from time of randomization until date of first recurrence or death due to any cause, assessed for up to 10 years. Secondary outcome measures include invasive disease-free survival (DFS); distant relapse-free survival; overall survival (OS); incidence and severity of adverse events (AEs) per the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0; change from baseline and time to deterioration (TTD) of health-related quality of life (QOL) per the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30; and pharmacokinetics of camizestrant. The study plans to enroll approximately 4300 participants throughout the United States and worldwide. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05774951.

The purpose of this randomized, open-label, phase 3 trial is to evaluate the efficacy and safety of gedatolisib (PKI-587) plus fulvestrant (Faslodex) with or without palbociclib (Ibrance) versus standard of care for the treatment of patients with locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer with disease progression on or after receiving CDK4/6 and aromatase inhibitor therapy. Patients aged ≥18 years with histologically or cytologically confirmed locally advanced or metastatic HR-positive, HER2-negative disease; who have adequate archival or fresh tumor tissue for PIK3CA mutational status analysis; who have radiologic disease progression on or after the last previous treatment and have radiologically evaluable disease according to RECIST version 1.1; who have an ECOG performance status of 0 or 1; and whose disease has progressed on or after CDK4/6 inhibitor combination treatment with a nonsteroidal aromatase inhibitor may be eligible if other criteria are met. Eligible patients will be randomized into 6 arms, based on PIK3CA mutation status. Patients with PIK3CA mutation–negative disease will be randomized to receive either gedatolisib 180 mg intravenous (IV) for 3 weeks on days 1, 8, and 15, plus palbociclib 125 mg orally (PO) daily for 3 weeks, and fulvestrant 500 mg intramuscular (IM) every 2 weeks in cycle 1 and every 4 weeks on day 1 of cycle 2; gedatolisib plus fulvestrant; or fulvestrant alone. Patients with PIK3CA mutation–positive disease will be randomized to receive either gedatolisib 180 mg IV for 3 weeks on days 1, 8, and 15, plus palbociclib 125 mg PO daily for 3 weeks, and fulvestrant 500 mg IM every 2 weeks in cycle 1 and every 4 weeks on day 1 of cycle 2; fulvestrant plus alpelisib (Piqray) 300 mg PO daily for 4 weeks; or gedatolisib plus fulvestrant.

The primary outcome measure is progression-free survival (PFS) from time of randomization to first documented progression or death, whichever comes first, per RECIST version 1.1. Secondary outcome measures include OS; overall response rate (ORR); duration of response (DOR); clinical benefit rate (CBR); TTD; change in baseline QOL Functional Assessment of Cancer Therapy (FACT)-Breast Trial Outcome Index; patient-reported outcomes; and type, incidence, and severity of AEs per NCI-CTCAE version 5.0. The study plans to enroll approximately 701 participants throughout the United States and worldwide. For more information, contact Nadene Zack, MS, at 1-844-310-3900 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05501886.

The purpose of this randomized, open-label, phase 3 study is to measure the efficacy of imlunestrant (LY-3484356) versus standard hormone therapy in patients with ER-positive, HER2-negative, early-stage, resected, invasive breast cancer who have received endocrine therapy for 2 to 5 years and have a higher-than-average risk for cancer recurrence. Patients aged ≥18 years with ER-positive, HER2-negative, early-stage, resected, invasive breast cancer without evidence of distant metastasis; who have received at least 2 years but not more than 5 years of any adjuvant endocrine therapy; who have an increased risk for disease recurrence based on clinical pathologic risk features; and who have an ECOG performance status of 0 or 1 may be eligible if other criteria are met. Eligible patients will be randomized to receive either imlunestrant PO or investigator’s choice of endocrine therapy (tamoxifen, anastrozole, letrozole, or exemestane).

The primary outcome measure is invasive DFS from randomization to recurrence or death from any cause for up to 10 years. Secondary outcome measures include distant recurrence-free survival (RFS); OS; pharmacokinetics of imlunestrant; change from baseline in EORTC QLQ-C30; and proportion of time on study treatment with high overall AE burden per FACT-General Physical Well-Being. The study plans to enroll approximately 6000 participants throughout the United States and worldwide. For more information, contact Eli Lilly and Company at 1-877-285-4559 or 1-317-615-4559 or This email address is being protected from spambots. You need JavaScript enabled to view it., or contact the recruiting sites directly. The NLM identifier is NCT05514054.

The purpose of this randomized, open-label, 3-arm, multicenter, international, phase 3 study is to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd; DS-1062) with or without durvalumab (Imfinzi) versus investigator’s choice of capecitabine (Xeloda) and/or pembrolizumab (Keytruda) for the treatment of patients with stage I to III triple-negative breast cancer (TNBC) with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy. Patients aged ≥18 years with histologically confirmed invasive TNBC with residual invasive disease; who have completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab; who have no evidence of locoregional or distant relapse; who have no known germline BRCA1 or BRCA2 mutation; and who have an ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomization may be eligible if other criteria are met. Eligible patients will be randomized to receive either Dato-DXd 6 mg/kg IV every 3 weeks for 8 cycles plus durvalumab 1120 mg IV every 3 weeks for 9 cycles; Dato-DXd 6 mg/kg IV every 3 weeks for 8 cycles alone; or investigator’s choice therapy of capecitabine 1000 or 1250 mg/m² PO twice daily on days 1 to 14 every 3 weeks for 8 cycles, pembrolizumab 200 mg IV on day 1 every 3 weeks for 9 cycles, or capecitabine plus pembrolizumab.

The primary outcome measure is invasive DFS for Dato-DXd plus durvalumab versus investigator’s choice from date of randomization until recurrence or death due to any cause up to 57 months. Secondary outcome measures include distant DFS; OS; invasive DFS; TTD of physical functioning and QOL; incidence of treatment-emergent AEs per NCI-CTCAE version 5.0; immunogenicity of Dato-DXd; and pharmacokinetics of Dato-DXd. The study plans to enroll approximately 1075 participants throughout the United States and worldwide. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05629585.

The purpose of this randomized, open-label, phase 3 study is to assess the efficacy and safety of adjuvant sacituzumab govitecan-hziy (Trodelvy) plus pembrolizumab versus investigator’s choice of pembrolizumab or pembrolizumab plus capecitabine for the treatment of patients with TNBC who have residual invasive disease after surgery and neoadjuvant therapy. Patients aged ≥18 years with residual invasive TNBC in the breast or lymph nodes after neoadjuvant therapy and surgery; who have had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes; who have an ECOG performance status of 0 or 1; and who have received appropriate radiotherapy and have recovered prior to starting study treatment may be eligible if other criteria are met. Eligible patients will be randomized to receive either sacituzumab govitecan 10 mg/kg IV on days 1 and 8 of 21-day cycles plus pembrolizumab 200 mg IV on day 1 of each 21-day cycle for 8 cycles; or pembrolizumab 200 mg IV on day 1 of each 21-day cycle for 8 cycles or pembrolizumab 200 mg IV on day 1 of each 21-day cycle for 8 cycles plus capecitabine 1000 mg/m² PO twice daily on days 1 to 14 of each 21-day cycle for 8 cycles.

The primary outcome measure is invasive DFS from date of randomization to death due to any cause for up to 60 months. Secondary outcome measures include OS; distant DFS; RFS; percentage of participants having a treatment-emergent AE; percentage of participants having laboratory abnormalities; and time to worsening QOL based on FACT-Breast Trial Outcome Index. The study plans to enroll approximately 1514 participants throughout the United States and worldwide. For more information, contact Gilead Clinical Study Information Center at 1-833-445-3230 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05633654.

The purpose of this randomized, open-label, phase 3 study is to measure the efficacy of imlunestrant alone versus standard endocrine therapy versus imlunestrant plus abemaciclib (Verzenio) in the treatment of patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer. Patients aged ≥18 years with ER-positive, HER2-negative, locally advanced or metastatic breast cancer with disease progression on or after an aromatase inhibitor alone or in combination with a CDK4/6 inhibitor; who have evaluable disease per RECIST version 1.1; and who have an ECOG performance status of 0 or 1 may be eligible if other criteria are met. Eligible patients will be randomized to receive either imlunestrant PO alone, investigator’s choice of endocrine therapy (exemestane PO or fulvestrant IM), or imlunestrant PO plus abemaciclib PO.

The primary outcome measures include PFS in the intent-to-treat (ITT) population and PFS in the ESR1 mutation–positive population, from date of randomization to date of first documented disease progression or death due to any cause for up to 3 years. Secondary outcome measures include OS in the ITT and ESR1 mutation–positive populations; ORR; DOR; CBR; PFS; patient-reported outcomes; and pharmacokinetics of imlunestrant alone and imlunestrant plus abemaciclib. The study plans to enroll approximately 860 participants throughout the United States and worldwide. For more information, contact Eli Lilly and Company at 1-877-285-4559 or 1-317-615-4559 or This email address is being protected from spambots. You need JavaScript enabled to view it., or contact the recruiting sites directly. The NLM identifier is NCT04975308.

The purpose of this randomized, parallel-assignment, open-label, phase 3 study is to compare the recurrence-free interval among patients with early-stage, low-risk, HER2-positive breast cancer who have received breast-conserving surgery and HER2-directed therapy and are randomized to not receive adjuvant breast radiotherapy versus those randomized to receive adjuvant radiotherapy per the standard of care. Patients aged ≥40 years who have had breast-conserving surgery and who have completed a minimum of 4 cycles (12 weeks) of neoadjuvant or adjuvant chemotherapy in combination with HER2-targeted therapy; who have histologically or cytologically confirmed invasive breast carcinoma; who have had axillary staging (either sentinel node biopsy or axillary lymph nodal dissection); and who have a Karnofsky performance status of >60 or an ECOG performance status of 0 to 2 may be eligible if other criteria are met. Eligible patients will be randomized to receive either their planned standard-of-care adjuvant breast radiation and systemic HER2-targeted therapies or standard-of-care systemic HER2-targeted therapy without adjuvant breast radiation.

The primary outcome measure is recurrence-free interval from randomization to first recurrence event or censoring for the duration of the trial, at 10.5 years. Secondary outcome measures include ipsilateral breast recurrence for radiation omitting arm and treatment arm; local regional recurrence, DFS, and OS by treatment arm; patient-reported breast pain by treatment arm using the Breast Cancer Treatment Outcome Scale; and patient-reported worry about recurrence by treatment arm. The study plans to enroll approximately 1300 participants throughout the United States and Puerto Rico. For more information, contact Judy Langer, MD, MS, at 1-412-339-5300 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05705401.