Clinical Trials in Breast and Endometrial Cancer

Pembrolizumab is being studied in clinical trials for the treatment of

Breast cancer is one of the three most common cancers diagnosed in women, and accounts for 30% of new cancer cases in women in the United States.[1] About one in eight women will develop malignant breast cancer over her lifetime.[2] Deaths from breast cancer in women have declined by 40% from 1989 to 2016[1] possibly due to treatment advances, earlier detection, and increased awareness.[2] Yet it is estimated that in 2019, 41,760 women will die of breast cancer, accounting for about 6.9% of all cancer deaths.[3]

Endometrial cancer is the most common cancer of the female reproductive organs among United States residents. The American Cancer Society estimates that about 61,880 cases of cancer of the uterine body will be diagnosed in 2019[4] accounting for about 3.5% of all new cancer cases.[5] Some 12,160 women will die from endometrial cancer in 2019. These estimates include both endometrial cancers and uterine sarcomas; sarcomas make up about 10% of uterine body cancers.[4]

Breast cancer is most frequently diagnosed in women between the ages of 55 and 64.[3] Black women are at higher risk of dying from this disease compared to women of other ethnicities. Risk is nearly double for women with a first-degree relative who have a history of breast cancer. In addition, about 5-10% of breast cancers can be linked to a germline gene mutation such as BRCA1 or BRCA2.[2] Breast cancers are generally categorized as hormone receptor positive (estrogen receptor and/or progesterone receptor positive), HER2-positive, or triple negative (absence of hormone receptor or HER2 mutations).

Endometrial cancer is uncommon in women under the age of 45 and mainly affects post-menopausal women; the average age of women diagnosed with endometrial cancer is 60 years. Based on 2014-2016 data from the National Cancer Institute, about 3.1% women will be diagnosed with uterine cancer during their lifetime. An estimated 772,245 women were living with uterine cancer in the United States in 2016.[5]

Many clinical trials are underway in all of these patient populations and recruiting patients to test novel therapies, approaches, and alleviate side effects of cancer therapies.

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IMpassion131).
ClinicalTrials.gov Identifier: NCT03125902.
Hoffmann-La Roche, 201 international locations.

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03].
ClinicalTrials.gov Identifier: NCT03529110.
Daiichi Sankyo, Inc./ Daiichi Sankyo Co., Ltd. & AstraZeneca, 120 international locations.

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer (EMERALD)
ClinicalTrials.gov Identifier: NCT03778931.
Radius Pharmaceuticals, Inc.,
55 international locations

Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy
ClinicalTrials.gov Identifier: NCT02332928.
Virginia Commonwealth University /National Cancer Institute, Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia

Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
ClinicalTrials.gov Identifier: NCT03927027.
Alliance for Clinical Trials in Oncology/ National Cancer Institute, 4 U.S. locations

Pivotal Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients
ClinicalTrials.gov Identifier: NCT03686215.
Lumicell, Inc./ National Cancer Institute, 16 U.S. sites

A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer (IMpassion132)
ClinicalTrials.gov Identifier: NCT03371017.
Hoffmann-La Roche, 110 international locations

Pembrolizumab in Treating Patients With Triple-Negative Breast Cancer
ClinicalTrials.gov Identifier: NCT02954874.
National Cancer Institute, 759 U.S. locations

Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy
ClinicalTrials.gov Identifier: NCT01901094.
Alliance for Clinical Trials in Oncology/ National Cancer Institute &
Canadian Cancer Trials Group, 1160 locations in the United States, Canada, and Puerto Rico

Platinum Based Chemotherapy or Capecitabine in Treating Patients With Residual Triple- Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy
ClinicalTrials.gov Identifier:NCT02445391. ECOG-ACRIN Cancer Research Group/ National Cancer Institute, 907 U.S. locations

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
ClinicalTrials.gov Identifier: NCT02488967.
NRG Oncology/ National Cancer Institute, 1296 locations in the United States and Canada

A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer (IMpassion030)
ClinicalTrials.gov Identifier: NCT03498716
Hoffmann-La Roche/ Breast International Group, Alliance Foundation Trials (AFT), Institut Jules Bordet/Clinical Trials Support Unit (IJB/CTSU), &Frontier Science and Technology Research Foundation Inc (FS),
423 international locations

MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
ClinicalTrials.gov Identifier: NCT01805076.
Alliance for Clinical Trials in Oncology/ National Cancer Institute & American College of Radiology Imaging Network, 178 U.S. locations

Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer
ClinicalTrials.gov Identifier: NCT02364557.
NRG Oncology/ National Cancer Institute, 160 U.S. locations

Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer
ClinicalTrials.gov Identifier: NCT03414970.
Alliance for Clinical Trials in Oncology/ National Cancer Institute & Canadian Cancer Trials Group,
748 locations in the United States and Canada

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
ClinicalTrials.gov Identifier: NCT03523585.
Daiichi Sankyo, Inc./ Daiichi Sankyo Co., Ltd. AstraZeneca, 144 international locations

A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer (IMpassion050)
ClinicalTrials.gov Identifier: NCT03726879.
Hoffman-La Roche/ Chugai Pharmaceutical, 84 international locations

A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy<
ClinicalTrials.gov Identifier: NCT03584009.
Hoffman-La Roche, 43 international locations

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (NATALEE)
ClinicalTrials.gov Identifier: NCT03701334.
Novartis Pharmaceuticals/ Translational Research in Oncology, 149 international locations

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)
ClinicalTrials.gov Identifier: NCT03725059.
Merck Sharp & Dohme Corp, 200 international locations

Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer (ASCENT)
ClinicalTrials.gov Identifier: NCT02574455.
Immunomedics, Inc., 230 international locations

Study of Adagloxad Simolenin (OBI-822) and OBI-821 Versus Placebo Treatment for High Risk Early Stage Triple Negative Breast Cancer Patients (TNBC) Following Neoadjuvant or Adjuvant Chemotherapy
ClinicalTrials.gov Identifier: NCT03562637. OBI Pharma, Inc., 92 international locations

A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer (IPATunity150)
ClinicalTrials.gov Identifier: NCT04060862.
Hoffmann-La Roche, 35 international locations

A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine (ATTAIN)
ClinicalTrials.gov Identifier: NCT02915744.
Nektar Therapeutics, 78 international locations

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer (MONARCH 2)
ClinicalTrials.gov Identifier: NCT02107703.
Eli Lilly and Company, 142 international locations

Endometrial Cancer Trials

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])
ClinicalTrials.gov Identifier: NCT03517449.
Eisai Inc./ Merck Sharp & Dohme Corp, 177 international locations.

Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
ClinicalTrials.gov Identifier: NCT03884101.
Merck Sharp & Dohme Corp, 55 international locations.

Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
ClinicalTrials.gov Identifier: NCT03914612.
National Cancer Institute/ NRG Oncology, Greater Baltimore Medical Center, Baltimore, Maryland.

Adjuvant Sequential & Concurrent CarboTaxol + Radiotherapy for High Risk Endometrial Cancer
ClinicalTrials.gov Identifier: NCT03935256.
Loyola University, Loyola University Medical Center Maywood, Illinois.

Health and Recovery Program in Increasing Physical Activity Level in Stage IA-IIIA Endometrial Cancer Survivors
ClinicalTrials.gov Identifier: NCT03367923.
Stanford University, 2 U.S. locations

Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy
ClinicalTrials.gov Identifier: NCT03671811.
City of Hope Medical Center/ National Cancer Institute, City of Hope Medical Center, Duarte, California.

ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma
ClinicalTrials.gov Identifier: NCT03394027.
National Cancer Institute, National Institutes of Health Clinical Center, Bethesda, Maryland.

Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
ClinicalTrials.gov Identifier: NCT03617679.
University of Colorado, Denver/ Clovis Oncology, Inc. & National Cancer Institute, University of Colorado Hospital, Aurora, Colorado.

A Study of Durvalumab With or Without Tremelimumab in Endometrial Cancer
ClinicalTrials.gov Identifier: NCT03015129.
Memorial Sloan Kettering Cancer Center, 8 New Jersey and New York locations.

Enzalutamide, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrioid Endometrial Cancer
ClinicalTrials.gov Identifier: NCT02684227.
M.D. Anderson Cancer Center, 6 locations in Texas.

Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent or Metastatic Endometrial Cancer
ClinicalTrials.gov Identifier: NCT03367741.
National Cancer Institute, 34 locations in the United States and Canada.

Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer
ClinicalTrials.gov Identifier: NCT02397083.
M.D. Anderson Cancer Center/ National Cancer Institute, 10 U.S. locations.

Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer
ClinicalTrials.gov Identifier: NCT00492778.
Gynecologic Oncology Group/ National Cancer Institute, 439 locations in the United States and Canada.

Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer
ClinicalTrials.gov Identifier: NCT03526432.
University of Oklahoma/ Genentech, Inc., Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.

Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer
ClinicalTrials.gov Identifier: NCT03099499.
Fox Chase Cancer Center/ Oncoceutics, Inc., Fox Chase Cancer Center, Philadelphia, Pennsylvania.

Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-alpha Positive Endometrial Cancer
ClinicalTrials.gov Identifier: NCT03832361.
Yale University/ ImmunoGen, Inc., Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut.

Pembrolizumab in Ultramutated and Hypermutated Endometrial Cancer
ClinicalTrials.gov Identifier: NCT02899793.
Yale University/ Merck Sharp & Dohme Corp, Yale New Haven Hospital, New Haven, Connecticut.

A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC)
ClinicalTrials.gov Identifier: NCT03835819.
Dana-Farber Cancer Institute/ ImmunoGen, Inc. & Merck Sharp & Dohme Corp., 2 U.S. locations.

Abemaciclib With Letrozole in Recurrent or Persistent Endometrial Cancer
ClinicalTrials.gov Identifier: NCT03675893.
Dana-Farber Cancer Institute/ Eli Lilly and Company, 3 U.S. locations.

Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
ClinicalTrials.gov Identifier: NCT03617679.
University of Colorado, Denver/ Clovis Oncology, Inc. & National Cancer Institute (NCI), University of Colorado Hospital, Aurora, Colorado.

Study of Ribociclib (LEE011), Everolimus, and Letrozole, in Patients With Advanced or Recurrent Endometrial Carcinoma
ClinicalTrials.gov Identifier: NCT03008408.
University of Colorado, Denver/ Clovis M.D. Anderson Cancer Center/ Novartis, M.D. Anderson Cancer Center, Houston, Texas.

The EndoBARR Trial (Endometrial Bevacizumab, Atezolizumab, Rucaparib) (EndoBARR)
ClinicalTrials.gov Identifier: NCT03694262.
Medical College of Wisconsin/ Genentech, Inc. & Clovis Oncology, Inc., Froedtert Lutheran Memorial Hospital, Milwaukee, Wisconsin.

Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer
ClinicalTrials.gov Identifier: NCT03572478.
University of Chicago/ Bristol-Myers Squibb & Clovis Oncology, Inc, University of Chicago Medical Center, Chicago, Illinois.

Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib in Patients With MSS Recurrent or Persistent Endometrial Cancer
ClinicalTrials.gov Identifier: NCT02912572.
Dana-Farber Cancer Institute/ Pfizer, 4 U.S. locations.

Financial Disclosure:The author and reviewer have no significant financial interest in or other relationship with the manufacturer of any product or provider of any service mentioned in this article. Breast Cancer Trials

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