NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




Breast Clinical Trials

Cancer clinical trials are research studies for developing better ways of detecting, treating, and eventually preventing cancer. By taking part in a clinical trial, you are among the first to receive new research treatments before they are widely available. Your participation in a clinical trial will influence the future direction of cancer care.

 

If you are interested in participating in a clinical trial, consult with your physician. Please note: clinical trials are not risk free. Patients must explore the options that are best for their individuals needs with the help of their physician.



Stage I

CTSU NSABP B-51 - "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"

CANCER TYPE: Stage I
RESEARCH BASE: CTSU NSABP B-51
NCT NUMBER:
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Adj., T1-3 N1, (+) axillary nodes b/f & (-) axillary nodes post-neoadjuv chemo; Eval of post-mastectomy chestwall + reg nodal XRT & post-lumpectomy reg nodal XRT (see RT credentialing requirements in protocol.)






NRG-BR003 - "A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer"

CANCER TYPE: Stage I
RESEARCH BASE: NRG
NCT NUMBER: NCT02488967
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Breast, female or male, triple neg, node pos or high risk node neg, invasive; adj doxorubicin+cyclophosphamide followed by paclitaxel w/w out carboplatin






NSABP B-55 - "A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant 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"

CANCER TYPE: Stage I
RESEARCH BASE: NRG/NSABP
NCT NUMBER: NCT02032823
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

High risk, TNBC, BRCA1 or BRCA2 positive mutation, Stage I-III, Olaparib vs Placebo post definitive local tx and chemo






SWOG 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 (E3 Breast Cancer Study - Evaluating Everolimus with Endocrine Therapy)"

CANCER TYPE: Stage I
RESEARCH BASE: SWOG S1207
NCT NUMBER: 01674140
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Adj., Stgs I-III, high-risk, ER &/or PgR+, HER2(-); Endocrine therapy + Everolimus/placebo






SWOG S1418 - "Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy"

CANCER TYPE: Stage I
RESEARCH BASE: SWOG
NCT NUMBER: NCT02954874
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

TNBC, > 1cm residual invasive breast cancer, or any + LN after neoadjuvant chemotherapy, followed by surgery, PD-L1 evaluation, MK-3475 (pembrolizumab) vs observation






Stage II

Alliance A011106 - "Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer NeoAdjuvant Treatment (ALTERNATE) in Postmenopausal Women"

CANCER TYPE: Stage II
RESEARCH BASE: Alliance A011106
NCT NUMBER: 01953588
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Neoadj., T2-T4 any N M0, ER+, post-menopausal; Anastrozole vs Fulvestrant vs both ---> Surgery ---> Endocrine therapy x 4.5 yrs (dependent on Modified PEPI score)






Alliance A011502 - "A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR NODE POSTIVE HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL"

CANCER TYPE: Stage II
RESEARCH BASE: Alliance
NCT NUMBER: NCT02927249
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Breast carcinoma, node positive, HER-2 negative, stage II or III, aspirin 300mg vs. placebo x 5 years






CTSU Alliance A011202 - "A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (CT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy"

CANCER TYPE: Stage II
RESEARCH BASE: CTSU Alliance A011202
NCT NUMBER:
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Post-Neoadj, T1-3N1M0 (prior to neoadjuv chemo); Eval of axillary LN dissection for positive sentinel LN disease






CTSU NSABP B-51 - "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"

CANCER TYPE: Stage II
RESEARCH BASE: CTSU NSABP-B51
NCT NUMBER:
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Adj., T1-3 N1, (+) axillary nodes b/f & (-) axillary nodes post-neoadjuv chemo; Eval of post-mastectomy chestwall + reg nodal XRT & post-lumpectomy reg nodal XRT (see RT credentialing requirements in protocol.)






NRG-BR003 - "A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer"

CANCER TYPE: Stage II
RESEARCH BASE: NRG
NCT NUMBER: NCT02488967
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Breast, node pos or high risk node neg, triple neg invasive; adj doxorubicin+cyclophosphamide followed by paclitaxel w/w out carboplatin






NSABP B-55 - "A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant 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"

CANCER TYPE: Stage II
RESEARCH BASE: NRG/NSABP
NCT NUMBER: NCT02032823
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

High risk, TNBC, BRCA1 or BRCA2 positive mutation, Stage I-III, Olaparib vs Placebo post definitive local tx and chemo






SWOG 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 (E3 Breast Cancer Study - Evaluating Everolimus with Endocrine Therapy)"

CANCER TYPE: Stage II
RESEARCH BASE: SWOG S1207
NCT NUMBER: 01674140
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Adj., Stgs I-III, high-risk, ER &/or PgR+, HER2(-); Endocrine therapy + Everolimus/placebo






SWOG S1418 - "Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy"

CANCER TYPE: Stage II
RESEARCH BASE: SWOG
NCT NUMBER: NCT02954874
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION
TNBC, > 1cm residual invasive breast cancer, or any + LN after neoadjuvant chemotherapy, followed by surgery, PD-L1 evaluation, MK-3475 (pembrolizumab) vs observation




Stage III

Alliance A011106 - "Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer NeoAdjuvant Treatment (ALTERNATE) in Postmenopausal Women"

CANCER TYPE: Stage III
RESEARCH BASE: Alliance A011106
NCT NUMBER: 01953588
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Neoadj., T2-T4 any N M0, ER+, post-menopausal; Anastrozole vs Fulvestrant vs both ---> Surgery ---> Endocrine therapy x 4.5 yrs (dependent on Modified PEPI score)






Alliance A011502 - "A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR NODE POSTIVE HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL"

CANCER TYPE: Stage III
RESEARCH BASE: Alliance
NCT NUMBER: NCT02927249
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Breast carcinoma, node positive, HER-2 negative, stage II or III, aspirin 300mg vs. placebo x 5 years






CTSU Alliance A011202 - "A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (CT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy"

CANCER TYPE: Stage III
RESEARCH BASE: CTSU Alliance A011202
NCT NUMBER:
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Post-Neoadj, T1-3N1M0 (prior to neoadjuv chemo); Eval of axillary LN dissection for positive sentinel LN disease






CTSU NSABP B-51 - "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"

CANCER TYPE: Stage III
RESEARCH BASE: CTSU NSABP B-51
NCT NUMBER:
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Adj., T1-3 N1, (+) axillary nodes b/f & (-) axillary nodes post-neoadjuv chemo; Eval of post-mastectomy chestwall + reg nodal XRT & post-lumpectomy reg nodal XRT (see RT credentialing requirements in protocol.)






ECOG-ACRIN E2112 - "A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer"

CANCER TYPE: Stage III
RESEARCH BASE: ECOG-ACRIN
NCT NUMBER: NCT02115282
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Breast, ER+ PR+ HER2 -, adenoca, stage III locally advanced or stage IV, Exemestane (or Goserelin) + Entinostat vs. Exemestane (or Goserelin) + Placebo






NRG-BR003 - "A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer"

CANCER TYPE: Stage III
RESEARCH BASE: NRG
NCT NUMBER: NCT02488967
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Breast, node pos or high risk node neg, triple neg invasive; adj doxorubicin+cyclophosphamide followed by paclitaxel w/w out carboplatin






NSABP B-55 - "A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant 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"

CANCER TYPE: Stage III
RESEARCH BASE: NRG/NSABP
NCT NUMBER: NCT02032823
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

High risk, TNBC, BRCA1 or BRCA2 positive mutation, Stage I-III, Olaparib vs Placebo post definitive local tx and chemo






SWOG 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 (E3 Breast Cancer Study - Evaluating Everolimus with Endocrine Therapy)"

CANCER TYPE: Stage III
RESEARCH BASE: SWOG S1207
NCT NUMBER: 01674140
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Adj., Stgs I-III, high-risk, ER &/or PgR+, HER2(-); Endocrine therapy + Everolimus/placebo






SWOG S1418 - "Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy"

CANCER TYPE: Stage III
RESEARCH BASE: SWOG
NCT NUMBER: NCT02954874
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION
TNBC, > 1cm residual invasive breast cancer, or any + LN after neoadjuvant chemotherapy, followed by surgery, PD-L1 evaluation, MK-3475 (pembrolizumab) vs observation




Stage IV

ECOG-ACRIN E2112 - "A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer"

CANCER TYPE: Stage IV
RESEARCH BASE: ECOG-ACRIN
NCT NUMBER: NCT02115282
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Breast, ER+ PR+ HER2 -, adenoca, stage III locally advanced or stage IV, Exemestane + Entinostat vs. Exemestane + Placebo






SWOG S1416 - "PHASE II RANDOMIZED PLACEBO-CONTROLLED TRIAL OF CISPLATIN WITH OR WITHOUT ABT-888 (VELIPARIB) IN METASTATIC TRIPLE-NEGATIVE BREAST CANCER AND/OR BRCA MUTATION-ASSOCIATED BREAST CANCER"

CANCER TYPE: Stage IV
RESEARCH BASE: SWOG
NCT NUMBER: NCT02595905
Protocol Summary: VIEW SUMMARY
Consent Form: VIEW CONSENT FORM
BRIEF DESCRIPTION

Breast, stage IV, triple negative and/or BRCA positive, cisplatin +/- ABT-888 (Veliparib)









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