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.
1 Trastuzumab Deruxtecan with or without Pertuzumab versus a Taxane, Trastuzumab, and Pertuzumab in HER2-Positive Metastatic Breast Cancer
The purpose of this randomized, open-label, phase 3 study is to evaluate the efficacy and safety of trastuzumab deruxtecan (Enhertu; T-DXd) alone or in combination with pertuzumab (Perjeta) versus the standard-of-care regimen of a taxane (docetaxel or paclitaxel), trastuzumab (Herceptin), and pertuzumab. Patients aged ≥18 years with pathologically documented advanced or metastatic, HER2-positive, and hormone receptor (HR)-positive or HR-negative breast cancer, who have not received previous chemotherapy or HER2-targeted therapy or who have received only 1 previous line of endocrine therapy may be eligible if other criteria are met. Eligible patients will be randomized to receive either T-DXd alone via intravenous (IV) infusion, T-DXd plus pertuzumab IV infusion, or investigator’s choice of a taxane plus pertuzumab and trastuzumab IV infusion.
The primary outcome measure is progression-free survival (PFS) by Blinded Independent Central Review assessment from the date of randomization until the date of objective radiological disease progression by RECIST version 1.1 or death due to any cause. Secondary outcome measures include PFS by investigator, overall survival (OS), objective response rate (ORR), duration of response (DOR), health-related quality of life (QoL) using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the safety and tolerability of T-DXd alone or with pertuzumab, and the serum concentration of T-DXd and pertuzumab. The study plans to enroll 1134 participants throughout the United States and worldwide. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or e-mail
2 Adjuvant Giredestrant versus Adjuvant Endocrine Monotherapy in ER-Positive, HER2-Negative Early Breast Cancer
The purpose of this randomized, parallel assignment, open-label, phase 3 study is to evaluate the efficacy and safety of adjuvant giredestrant (GDC-9545) versus investigator’s choice of adjuvant endocrine monotherapy in patients with estrogen receptor (ER)-positive, HER2-negative early breast cancer. Patients aged ≥18 years with multicentric and/or multifocal breast cancer, who have had definitive surgery of their primary breast tumor(s) and axillary lymph nodes, who have received or will be receiving adjuvant chemotherapy completed 21 days before randomization, and who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 may be eligible if other criteria are met. Eligible patients will receive giredestrant 30 mg orally once daily and a luteinizing hormone-releasing hormone agonist for male and premenopausal/postmenopausal patients, or investigator’s choice of endocrine therapy of tamoxifen or letrozole (Femara), anastrozole (Arimidex), or exemestane (Aromasin) on days 1 to 28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity, whichever comes first.
The primary outcome measure is invasive disease-free survival (DFS), excluding second primary nonbreast cancers, from time of randomization to first occurrence of invasive DFS event up to 10 years. Secondary outcome measures include OS, invasive DFS, DFS, distant recurrence-free interval and locoregional recurrence-free interval, the mean physician functioning scale score at specified timepoints and the change from baseline using the EORTC QLQ-C30, the incidence and severity of adverse events (AEs) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, and plasma concentrations of giredestrant. The study plans to enroll 4100 participants throughout the United States and worldwide. For more information, contact Hoffmann-La Roche at 1-888-662-6728 or e-mail
3 Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine in High-Risk, HER2-Positive Breast Cancer After Preoperative Chemotherapy
The purpose of this randomized, parallel assignment, double-blind, placebo-controlled, phase 3 study is to evaluate the efficacy and safety of adjuvant atezolizumab (Tecentriq) or placebo and trastuzumab emtansine (Kadcyla) in patients with HER2-positive primary breast cancer at high risk for recurrence following preoperative chemotherapy and HER2-directed therapy with a finding of residual invasive disease in the breast and/or axillary lymph nodes. Patients aged ≥18 years with histologically confirmed invasive breast carcinoma with centrally confirmed HER2-positive disease, who have completed preoperative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (Herceptin), who have an ECOG performance status of 0 or 1, and who have a life expectancy of ≥6 months may be eligible if other criteria are met. Eligible patients will receive either trastuzumab emtansine 3.6 mg/kg IV plus placebo every 3 weeks for 14 cycles, or atezolizumab 1200 mg IV plus trastuzumab emtansine 3.6 mg/kg IV every 3 weeks for 14 weeks.
The primary outcome measure is invasive DFS, defined as the time from randomization to the first occurrence of ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, contralateral invasive breast cancer, distant recurrence, or death from any cause. Secondary outcome measures include DFS; OS; mean change in baseline scores in QoL, physical, role, and cognitive function per EORTC QLQ-C30; the percentage of patients with AEs per NCI CTCAE version 5.0; the percentage of patients with antidrug antibodies to atezolizumab and trastuzumab emtansine; and the minimum serum concentrations of atezolizumab. The study plans to enroll 1700 participants throughout the United States and worldwide. For more information, contact Hoffmann-La Roche at 1-888-662-6728 or e-mail
4 Capivasertib plus Fulvestrant versus Placebo plus Fulvestrant in Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
The purpose of this randomized, parallel, double-blind, phase 3 study is to assess the efficacy and safety of capivasertib (AZD5363) plus fulvestrant (Faslodex) versus fulvestrant alone as treatment for locally advanced (inoperable) or metastatic HR-positive, HER2-negative breast cancer after disease recurrence or progression on or after treatment with an aromatase inhibitor. Patients aged ≥18 years with histologically confirmed metastatic or locally advanced HR-positive, HER2-negative disease, who have an ECOG performance status of 0 or 1, who have measurable disease according to RECIST version 1.1, and who received treatment with an aromatase inhibitor regimen and have radiological evidence of breast cancer recurrence or progression while on or within 12 months of the end of (neo)adjuvant treatment with an aromatase inhibitor or radiological evidence of progression while on previous aromatase inhibitor administered as a treatment line for locally advanced or metastatic breast cancer may be eligible if other criteria are met. Eligible patients will receive intramuscular fulvestrant 500 mg on day 1 of weeks 1 and 3 of cycle 1, and then on day 1 of week 1 of each cycle thereafter plus capivasertib 400 mg orally twice daily on days 1 to 4 each week of a 28-day treatment cycle, or fulvestrant alone.
The primary outcome measure is PFS in the overall population and in patients with PIK3CA, AKT1, and PTEN alterations, from date of randomization to the date of progression or death due to any cause, whichever occurs earlier, up to approximately 51 months. Secondary outcome measures include OS, DOR, ORR, the clinical benefit rate, the occurrence/frequency of AEs and its relationship to the study’s drugs, and the EORTC QLQ-C30. The study plans to enroll 834 participants throughout the United States and worldwide. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479, or e-mail
5 Atezolizumab plus Adjuvant Anthracycline/Taxane-Based Chemotherapy versus Chemotherapy Alone in Triple-Negative Breast Cancer
The purpose of this randomized, multicenter, open-label, phase 3 study is to evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab (Tecentriq) in combination with paclitaxel or paclitaxel alone, followed by atezolizumab, investigator’s choice of dose-dense doxorubicin or epirubicin (Ellence), and cyclophosphamide in patients with stage II-III triple-negative breast cancer. Patients aged ≥18 years with nonmetastatic, operable, stage II-III, and histologically documented disease, who have adequate hematologic and end-organ function, who have had either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy, and who have had definitive breast surgery <8 weeks before randomization may be eligible if other criteria are met. Eligible patients will receive atezolizumab 840 mg IV every 2 weeks for 10 doses plus paclitaxel 80 mg/m2 IV every week for 12 weeks, investigator’s choice of dose-dense doxorubicin or epirubicin, and cyclophosphamide 600 mg/m2 IV every 2 weeks for 4 doses, versus paclitaxel, dose-dense doxorubicin or epirubicin, and cyclophosphamide.
The primary outcome measure is invasive DFS from date of randomization until the first occurrence of invasive DFS event or death, through the end of the study (approximately 7 years). Secondary outcome measures include OS, DFS, recurrence-free interval, the percentage of patients with AEs, invasive DFS, the percentage of patients with antidrug antibodies, and mean changes from baseline in patient-reported, health-related QoL per EORTC QLQ-C30. The study plans to enroll 2300 participants throughout the United States and worldwide. For more information, contact Hoffmann-La Roche at 1-888-662-6728, or e-mail
6 Trastuzumab Emtansine with or without Tucatinib for the Prevention of Relapse in High-Risk, HER2-Positive Breast Cancer
The purpose of this randomized, double-blind, phase 3 study is to assess the efficacy of the combination of trastuzumab emtansine (Kadcyla; T-DM1) and tucatinib (Tukysa) for preventing relapse in patients with high-risk, HER2-positive breast cancer. Patients aged ≥18 years with clinical stage I-IV HER2-positive breast cancer with residual invasive disease postoperatively, who have received neoadjuvant chemotherapy and have not received previous T-DM1 in the neoadjuvant setting, who have had adequate excision of all clinically evident disease in the breast and lymph nodes, and who have an ECOG performance status of 0 or 1 may be eligible if other criteria are met. Eligible patients will receive T-DM1 IV over 30 to 90 minutes on day 1 and either oral placebo or tucatinib twice daily on days 1 to 21, with treatment repeating every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
The primary outcome measure is modified invasive DFS from time to randomization to invasive local, regional, or distant recurrence; invasive contralateral breast cancer; or death from any cause, assessed up to 10 years. Secondary outcome measures include unmodified invasive DFS, breast cancer–free survival, distant recurrence-free survival, brain metastases–free survival, and OS. The study plans to enroll 1031 participants throughout the United States and worldwide. For more information, contact Ciara C. O’Sullivan, MB BCh, BAO, at 1-507-293-0526, or e-mail
7 Camizestrant plus Palbociclib versus Anastrozole plus Palbociclib in Treatment-Naïve, ER-Positive, HER2-Negative, Advanced or Metastatic Breast Cancer
The purpose of this randomized, multicenter, double-blind, phase 3 study is to evaluate the superiority, safety, and efficacy of camizestrant (AZD9833) in combination with palbociclib (Ibrance) versus anastrozole (Arimidex) and palbociclib as initial treatment of patients with ER-positive, HER2-negative, advanced or metastatic breast cancer. Patients aged ≥18 years with de novo stage IV disease or recurrence from early-stage disease after standard adjuvant endocrine therapy; who have histologically or cytologically documented ER-positive, HER2-negative breast cancer; who have not been treated with any systemic anticancer therapy; who have adequate organ and marrow function; and who have an ECOG performance status of 0 or 1 may be eligible if other criteria are met. Eligible patients will receive either camizestrant 75 mg orally once daily plus palbociclib 125 mg orally once daily for 21 days followed by 7 days off treatment plus placebo once daily, or anastrozole 1 mg orally once daily plus palbociclib 125 mg orally once daily for 21 days followed by 7 days off treatment, and placebo orally once daily.
The primary outcome measure is PFS per RECIST version 1.1 from randomization until disease progression or death due to any cause. Secondary outcome measures include OS, ORR, DOR, time to chemotherapy, time to first and second subsequent therapy, plasma concentration of camizestrant, and changes from baseline in EORTC QLQ-C30. The study plans to enroll 1402 participants throughout the United States and worldwide. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or e-mail