CHC – The Cancer & Hematology Centers

Breast

Name of TrialTropion 04

What type of cancer is this for?  Triple Negative Breast Cancer

Phase of this trial? 3

Who is the trial for? Men or women diagnosed with Stage II or III bilateral or unilateral primary invasive breast cancer.   who have not yet had surgery or plan to not have surgery.

What biomarkers/mutations are necessary?  HER2-, HR – or HR low

What is the National Clinical Trials info? NCT06112379   

Brief summary of Trial: The is a randomized study looking at effectiveness and safety of pre-surgical Dato-DXd plus durvalumab, followed by post-surgical durvalumab with or without chemotherapy.  Compared with pre-surgical pembrolizumab plus chemo, followed by post-surgical pembrolizumab with or without chemotherapy, in previously untreated participants.

Need to know: Stage II or III localized breast cancer patients who require pre-surgical treatment, and is newly diagnosed with breast cancer that is triple negative, or low hormone receptor negative.

Where is this trial available? The Cancer & Hematology Centers and other sites nationwide, please click on link above to review.

For more information, please call 616-975-3065 or email [email protected]


Name of Trial? Capitello-292

Phase of this trial? Phase 3

Who is this trial for?  Men and Women with hormone positive, HER2 negative breast cancer that is locally advanced and inoperable.

What biomarkers are involved? None

Clinical Trial # NCT04862663  

Brief Summary of Trial:  This is a randomized 1:1 trial that is looking at new drug Capivasertib in combination with anti-hormone drug and a CDK4/6 inhibitor (oral drug), vs. anti-hormone drug plus CDK4/6 inhibitor.  The study is looking for which works best.

Need to Know: Must have relapsed on or within 12 months of completing first line endocrine therapy (such as Tamoxifen, or another AI), maximum of 1 line of chemotherapy in advanced disease setting. 

Where is this trial available?  Cancer and Hematology Centers and other sites nationwide, please click on link for other locations,

For more information, please call 616-975-3065 or email [email protected] 


Name of the trial?  INAVO 121

What type of cancer is this for?  Metastatic HER+/HER2- Breast Cancer

Phase of trial?  Phase 3

Who is this trial for?  Men and post-menopausal women, who have locally recurrent or metastatic breast cancer, who have only had 2 previous lines of treatment in the metastatic setting.

What biomarkers are involved?  HR+, HER2-, PIK3CA

What is the National Clinical Trial #?  NCT05646862 

Summary of the trial: A randomized study Evaluating the Efficacy and Safety of Inavolisib (Oral drug) Plus Fulvestrant (Hormone injection) Compared With Alpelisib (Oral drug) Plus Fulvestrant (Hormone injection).

Need to know information:  Can only have had 2 prior treatments in metastatic setting, must have PIK3CA mutation which will be tested with tissue from previous biopsy, cannot have Type 1 diabetes, or Type 2 diabetes that requires treatment.

Where is this trial available? The Cancer & Hematology Centers and other sites nationwide, please click on link above to review.

For more information, please call 616-975-3065 or email [email protected]


Name of this trial: ELAINE 3

What type of cancer is this for? BREAST

Phase of this trial: Phase III

Who is this trial for? Men and Women with Breast Cancer that has spread to other parts of the body.

What biomarkers are involved? You must have estrogen receptor positive,  HER2 negative Breast Cancer with an ESR1 Mutation

What is National Clinical Trial #?  NCT05696626

Brief summary of trial:  This trial compares how effective and safe the combination of Lasofoxifene and Abemaciclib is, compared to the combination of Fulvestrant and Abemaciclib. Lasofoxifene and Abemaciclib are both pills, and Fulvestrant is an injection.

Need to know: You must have tried Ribociclib or palbociclib-based treatment before.

Where is this trial available? The Cancer & Hematology Centers and other sites nationwide, please click on link above to review.

For more information, please call 616-975-3065 or email [email protected]


Name: SERENA 6

What type of cancer is this for? BREAST

Phase: III

Who is this trial for? Men and women with Breast Cancer that has spread to other parts of the body.

What biomarkers are involved? You must be hormone receptor (HR) positive, HER2 negative and have a positive ESR1 mutation

What is National Clinical Trial #? NCT04964934

Brief summary of trial: This trial looks to see how well AZD9833 (the drug that is being studied) plus palbociclib or abemaciclib works compared to either anastrozole or letrozole plus palbociclib or abemaciclib.

Need to know: You must have tried either anastrozole or letrozole plus a CDK4/6 inhibitor (Abemaciclib, Palbociclib or Ribociclib)

Where is this trial available?: The Cancer & Hematology Centers

For more information, please call 616-975-3065 or email [email protected]


Name of this trial? BEGONIA

What type of cancer is this for? BREAST

Phase of this trial? Phase II

Who is this trial for? Men and Women with breast Cancer that has spread to other parts of the body.

What biomarkers are involved? You must have estrogen receptor negative, progesterone receptor negative and HER2 negative breast cancer.

What is the National Clinical Trial #? NCT03742102

Brief summary of trial: This trial is looking to see how safe and well-tolerated Durvalumab and datopotamab deruxtecan are.

Need to know: You can have had treatment for your breast cancer before it spread, but now that it has spread, this has to be the first treatment you receive for it.

Where is this trial available?: The Cancer & Hematology Centers and other sites nationwide, please click on link above to review.

For more information, please call 616-975-3065 or email [email protected]


Name of this trial: GILEAD ASCENT-05

What type of cancer is this for? BREAST Cancer Triple Negative

Phase of this trial: Phase III

Who is this trial for? Men and Women with Breast Cancer early stage not cured with chemotherapy and surgery.

What biomarkers are involved? You must have estrogen receptor negative, progesterone receptor negative, and HER2 negative Breast Cancer

What is National Clinical Trial #? NCT05633654  

Brief summary of trial:  This trial compares how effective and safe the combination of Sacituzumab Govitecan and Pembrolizumab is, compared to treatment of physician’s choice in patients with triple negative breast cancer who have residual invasive disease after surgery and neoadjuvant therapy.

Need to know: Must have had neoadjuvant treatment and surgery for breast surgery with residual disease.

Where is this trial available? The Cancer & Hematology Centers and other sites nationwide, please click on link above to review.

For more information, please call 616-975-3065 or email [email protected]