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Breast Cancer Trials

Cancer Research Trials

Adjuvant- HER2+

BRE 227 IST

A randomized Phase II study of Trastuzumab-DM1 (antibody drug conjugate) vs Paclitaxel in combination with Trastuzumab for Stage I HER2-positive Breast Cancer

BRE 233 IST

A Randomized, Multicenter, Open-Label Trial Comparing Chemotherapy Plus Trastuzumab Plus Pertuzumab (Anti-HER2 Antibody) Versus Chemotherapy Plus Trastuzumab Emtansine Plus Pertuzumab As Adjuvant Therapy In Patients With Operable HER2 Positive Primary Breast Cancer (KAITLIN)

Adjuvant

BRE 186 IIT

Phase 2 Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy *Cohort C (Her 2+) is only cohort enrolling!

Adjuvant

BRE 224 IST *CMC Only

A single arm, preoperative, pilot study to evaluate the safety and biological effects of orally administered reparixin in early breast cancer patients who are candidates for surgery.

BRE 238 IST

A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin in Combination with Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (TNBC).

Metastatic, Refractory

BRE 203

A Phase II trial with TAK -700 in Metastatic breast cancer patients with tumors that express the Androgen Receptor (AR) (TNBC and ER/PR+)

REFMAL 312 IST *DDU Only

A Phase I, open-label, multiple ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0010718C (PD-L1) in subjects with metastatic or locally advanced solid tumors and expansion to selected indications

BRE 237 IST

A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of BMN 673 versus Physician's Choice in Germline BRCA Mutation Subjects with Locallky Advanced and/or Metastatic Breast Cancer, Who Have Received No More than 2 Prior Chemotherapy Regiments for Metastatic Disease (First-3rd line ONLY)

BREAST Metastatic, First-Line, HER2+

BRE 208
IST 

An Observational Cohort Study of Treatment Patterns and Outcomes in Patients with HER2 Positive (HER 2+) Metastatic Breast Cancer (SyStHERS)

BREAST Metastatic, First-Line, HER2-

BRE 166
IIT 

Use of the PRO Onc Assay to Assess HER2 Overexpression and Activation in Patients with Metastatic Breast Cancer Whose Tumors are HER2-Negative by Standard FISH Testing (Patients with HER2 overexpression/activation by PRO Onc Assay will receive trastuzumab/pertuzumab per protocol )

Metastatic, First-Line, ER/PR Positive

BRE 221
IIT 

A randomized, multicenter, double blind phase 3 study of PD-0332991 (oral CDK 4/6 inhibitor) plus Letrozole versus placebo plus Letrozole for the treatment of postmenopausal women with ER (+), HER 2 (-) breast cancer who have not received any prior systemic anti-cancer treatment for advanced disease

BRE 234 IST

A randomized double-blind, placebo-controlled study of LEE011 (CDK 4/6 Inhibitor) in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2 negative, advanced breast cancer who received no prior therapy for advanced disease

BREAST Metastatic, Refractory, HER2-

BRE 214

A Single Arm, Open-Label, Phase 2 Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Patients with Relapsed or Refractory Advanced Breast Cancer Whose Tumors Express HER2 at the 2+ Level by Immunohistochemistry and Lack Evidence of HER2 Gene Amplification by FISH

BRE 225 IST *DDU Only

A phase 1, open-label, dose escalation study to evaluate the safety and tolerability of SGN-LIV1A in patients with LIV-1-positive metastatic breast cancer

BRE 236 IST

A Phase 3 Randomized Trial of Niraparib versus Physician’s Choice in Patients with Her2 Negative Germline BRCA Mutation and Previously-Treated Breast Cancer (First-3rd line ONLY)

BRE 237 IST

A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of BMN 673 versus Physician's Choice in Germline BRCA Mutation Subjects with Locallky Advanced and/or Metastatic Breast Cancer, Who Have Received No More than 2 Prior Chemotherapy Regiments for Metastatic Disease (First-3rd line ONLY)

BRE 241 IST

A Phase 2 Study of LY2835219 for Patients with Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (Second and Third Line only)

Metastatic, Refractory, ER/PR Positive

BRE 196
IST *DDU Only

A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 (MTOR Inhibitor) Administered Orally in Combination with Intramuscular (IM) Fulvestrant to Patients with Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer

BRE 203 IIT

A Phase II trial with TAK -700 in Metastatic breast cancer patients with tumors that express the Androgen Receptor (AR) (TNBC and ER/PR+)

BRE 211 IST *DDU Only

A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enzalutamide (formerly MDV3100) (AR Signaling inhibitor) in Patients with Incurable Breast Cancer

BRE 217 IST

A three-arm, randomized, open label, phase II study of everolimus in combination with exemestane versus everolimus alone versus capecitabine in the treatment of postmenopausal women with estrogen receptor positive, locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on prior letrozole or anastrozole(Bolero 6)

BRE 218 IST

COMETI P2 Trial: Characterization of Circulating Tumor Cells from Patients with Metastatic Breast Cancer Using the CTC- Endocrine Therapy Index

BRE 226 IST *DDU Only

A phase Ib/II, multicenter, study of the combination of LEE011 and BYL719 with letrozole in adult patients with advanced ER+ breast cancer

BRE 229 IST

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide (AR inhibitor) in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor-Positive and HER2-Normal

BRE 239 IST

A Phase 1b Study of LY2835219 in Combination with Endocrine Therapies for Patients with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

BRE 241 IST

A Phase 2 Study of LY2835219 for Patients with Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (Second and Third Line only)

BREAST Metastatic, Refractory, HER2+

BRE 155 IST

An Open-Label, Multicenter Extension Study of Trastuzumab-MCC-DM1 (T-DM1) in Patients Previously Treated with T-DM1 in a Genentech-Sponsored T-DM1 Study

BRE 199
IST *DDU Only

A PHASE I, OPEN-LABEL, PARALLEL GROUP, PHARMACOKINETIC STUDY OF TRASTUZUMAB EMTANSINE (T-DM1) IN PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER AND NORMAL OR REDUCE HEPATIC FUNCTION

BRE 200
IIT *Lead in Portion Only

A Phase II Study with Lead-in Safety Cohort of Cabazitaxel plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients with Intracranial Metastases

BRE 230
IST *DDU Only

A Phase 1b, open-label study to assess the safety and tolerability of ONT-380 (Oral HER2 TKI) combined with ado-trastuzumab emtansine (T-DM1) (No Prior TDM-1)

BRE 235
IST *DDU Only

A Phase 1b, open-label study to assess the safety and tolerability of ONT-380 combined with capecitabine and trastuzumab, alone and in combination

BREAST Metastatic, Triple Negative, First- Line

BRE 223 IST

Phase 2/3, multi-center, open-label, randomized study of weekly nab-paclitaxel (ABRAXANE®) in combination with gemcitabine or carboplatin, compared to gemcitabine/carboplatin, as first-line treatment in subjects with ER, PR, and HER2 negative (triple negative) metastatic breast cancer

BRE 222 IST

A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Clinical Activity and Safety of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple-Negative Breast Cancer

BRE 231 IST

A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (The “METRIC” Study)

BREAST Refractory, Triple Negative

BRE 203 IIT

A Phase II trial with TAK -700 in Metastatic breast cancer patients with tumors that express the Androgen Receptor (AR) (TNBC and ER/PR+)

BRE 214 IST

A Single Arm, Open-Label, Phase 2 Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Patients with Relapsed or Refractory Advanced Breast Cancer Whose Tumors Express HER2 at the 2+ Level by Immunohistochemistry and Lack Evidence of HER2 Gene Amplification by FISH

BRE 222 IST

A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Clinical Activity and Safety of Enzalutamide (AR Signaling Inhibitor) in Patients With Advanced, Androgen Receptor-Positive, Triple-Negative Breast Cancer

BRE 225 IST *DDU Only

A phase 1, open-label, dose escalation study to evaluate the safety and tolerability of SGN-LIV1A in patients with LIV-1-positive metastatic breast cancer

BRE 236 IST

A Phase 3 Randomized Trial of Niraparib versus Physician’s Choice in Patients with Her2 Negative Germline BRCA Mutation and Previously-Treated Breast Cancer (First-3rd line ONLY)

BRE 237 IST

A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of BMN 673 versus Physician's Choice in Germline BRCA Mutation Subjects with Locallky Advanced and/or Metastatic Breast Cancer, Who Have Received No More than 2 Prior Chemotherapy Regiments for Metastatic Disease (First-3rd line ONLY)

This is a list of all trials open to accrual. For more information, please call 877-691-7274.