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Breast Cancer

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Breast Genomics 

"Identification of MicroRNA Biomarkers for the Risk Stratificaiton of Breast Cancer"

Principal Investigator: Ganepola Ganepola, M.D.



MonarchE 

A randomized, open-label, phase 3 study of abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone in patients with high risk, node positive, early stage, hormone receptor positive human epidermal receptor 2 negative, breast cancer

Treatment Arms:

  • Arm A: abemaciclib + SoC endocrine Tx
  • Arm B: SoC endocrine Tx alone


Patient Population:

  • ER/PR (+), HER2 (-)
  • Falls into one of the below high-risk groups:
    • s/p neoadjuvant chemo -> surgery -> >1 positive node, and one of the following:
      • Ki-67 >20%
      • Histologic grade 3
      • >5 cm primary tumor
    • s/p surgery -> 1-3 positive nodes, and one of the following:
      • Ki-67 >20%
      • Histologic grade 3
      • >5 cm primary tumor
    • s/p surgery -> >4 positive nodes


Principal Investigator: Eleonora Teplinsky, M.D.



IORT 

This is a data collection registry for women who will have intra-operative radiation therapy (IORT) as part of their cancer treatment at The Valley Hospital.  

Principal Investigator: Chad DeYoung, M.D.



Impassion 132 

A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer

  • Arm 1: Participants will receive Atezolizumab on day 1 of each 3-week treatment cycle
  • Arm 2: Participants will receive Placebo on day 1 of each 3-week treatment cycle

Principal Investigator: Eleonora Teplinsky, M.D.

Click here for more information on Impassion 132



POLARIS 

Polaris: Palbociclib In Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non-Interventional Study


Primary Outcome Measures: 

  • Clinical outcome [Timeframe: Reporting will be based on sample size and follow-up time through 2022.]
  • Progression free survival: the time from the start date of palbociclib to the date of the progression of disease or death according to investigator's assessment
  • Patient quality of life, as measured by EORTC QLQ-C30 [Timeframe: Reporting will be based on sample size and follow-up time through 2022.]
  • Geriatric Assessments in patients equal to or greater than 70 years of age at enrollment, as assessed by G8 Screening Tool [Timeframe: Reporting will be based on sample size and follow-up time through 2022.]
  • Geriatric Assessments in patients equal to or greater than 70 years of age at enrollment, as assessed by Activities of Daily Living [Timeframe: Reporting will be based on sample size and follow-up time through 2022.]
  • Biomarker Assessment [Timeframe: Reporting will be based on sample size and follow-up time through 2022.]
Study Population: HR+/HER2- ABC patients whose treatment decision with palbociclib has been made by their treating physician and who meet the eligibility criteria will be invited to participate in the study.
 

Principal Investigator: Thomas Rakowski, M.D.

Click here for more information on POLARIS



OlympiA 

“Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA)”

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.

Principal Investigator: Eleonora Teplinsky, M.D.

Click here for more information on OlympiA



EA1131 

“Platinum Based Chemotherapy or Capecitabine in Treating Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy”

Study Objective: This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.

Principal Investigator: Eleonora Teplinsky, M.D.

Click here for more information on EA1131



S1207 

"Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer."

Study Objective: To compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR)-positive, and human epidermal growth factor receptor (HER)2-negative breast cancer.

  • Arm 1: Chemotherapy + endocrine therapy
  • Arm 2: Endocrine therapy

Principal Investigator: Eli Kirshner, M.D.

Click here for more information on S1207



2014-0043 

"Phase II Trial of Combination Immunotherapy with nelipepimut-S + GM-CSF (NeuVax) and Trastuzumab in High-Risk HER2+ Breast Cancer Patients"

Study Objective: To assess the ability of the combination of trastuzumab and the HER2 vaccine nelipepimut-S (administered with the immunoadjuvant GM-CSF) given in the adjuvant setting to prevent recurrences in patients with high-risk HER2-positive breast cancer.

  • Arm 1: Trastuzumab + NeuVax
  • Arm 2: Trastuzumab  + GM-CSF

Principal Investigator: Thomas Rakowski, M.D.

Click here for more information on 2014-0043



ML25749 

"Combination Immunotherapy with Herceptin and the HER2 Vaccine in E75 in Low and Intermediate HER2- Expressing Breast Cancer Patients to Prevent Recurrence"

Study Objective: To assess the ability of the combination of Herceptin and the HER2 vaccine E75 (administered with the immunoadjuvant GM-CSF) given in the adjuvant setting to prevent recurrences in NP (or NN if negative for both estrogen [ER] and progesterone [PR] receptors) breast cancer patients with tumors that express low (1+) or intermediate (2+) levels of HER2.

  • Arm 1: Herceptin + NeuVax vaccine
  • Arm 2: Herceptin  + GM-CSF only

Principal Investigator: Thomas Rakowski, M.D.

Click here for more information on ML25749


 

NSABP B-51 / RTOG 1304

"A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy"

Study Objective: This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy X rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer.

  • Arm 1A: Lumpectomy + Whole breast irradiation
  • Arm 1B: Mastectomy
  • Arm 2A: Lumpectomy + regional nodal XRT + whole breast irradiation
  • Arm 2B: Mastectomy + regional nodal XRT + chestwall XRT

Principal Investigator: Laura Klein, M.D.

Click here for more information on NSABP B-51



A011401

"A Randomized Phase III Trial Evaluating the Role of Weight Loss and Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer"

Study Objective: This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence).

  • Arm 1: Health education program
  • Arm 2: Health education program + weight loss interventions

Principal Investigator: Tihesha Wilson, M.D.

Click here for more information on A011401



IMPASSION131

"A phase III, multicenter, randomized, double-blind, placebo-controlled study of atezolizumab (anti-PD-L1 antibody) in combination with paclitaxel compared with placebo with paclitaxel for patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer"

2 (Arm A) : 1 (Arm B) randomization
 
  • Arm A: paclitaxel + atezolizumab
  • Arm B: paclitaxel + placebo

Key Eligibility Criteria:
 
  • ER/PR 0%, HER-2 negative
  • No prior treatment in the locally advanced/metastatic setting
  • Completed previous chemotherapy for early breast cancer > 12 months ago
 


IMPASSION031

"A phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple Negative Breast Cancer"
 
Study Objective: This is a global Phase III, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).
 
  • Arm A: Nab-paclitaxel + Doxorubicin + Cyclophosphamide
  • Arm B: Nab-paclitaxel + Doxorubicin + placebo

Principal Investigator:Thomas Rakowski, M.D.
 

 

COMET (Aft-25)

"Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial for Low Risk DCIS: A Phase III Prospective Randomized Trial"
 
This study looks at the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC.
 
Arms:
  • Group 1: Guideline-Concordant Care (surgery +/- radiation and choice of endocrine therapy) 
  • Group 2: Active Surveillance (mammograms q 6 months and choice of endocrine therapy)
 
Key Inclusion/Exclusion Criteria:
  • Newly diagnosed low to intermediate grade DCIS (unilateral, bilateral, unifocal, or multifocal okay)
  • Or positive DCIS margins after lumpectomy
  • No documented mass on exam or imaging prior to biopsy
  • No prior invasive disease or history of endocrine therapy
 
Principal Investigator: Moira Christoudias, M.D.
 


The Valley Hospital Biorepository

For The Valley Hospital (TVH) patients undergoing surgical procedures, we offer the opportunity to participate in TVH Biorepository.  This protocol involves the freezing and storage of extra tissue not used for diagnosis, blood and other bodily fluids that may be used for future research designed to develop or contribute to generalized knowledge in cancer research.



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