Breast Cancer Trials

Neoadjuvant- HER2-positive

BRE 246 CMC only

A Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine And Pertuzumab Alone Or In Combination With Chemotherapy For Patients With HER2-Positive Breast Cancer

Neoadjuvant- Triple negative or BRCA mutant

BRE 238

Phase 3 Study Evaluating the Safety and Efficacy of of Veliparib (PARP inhibitor) Plus Carboplatin vs Carboplatin in Combination with Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects with Early Stage TNBC

Adjuvant- Pre-surgery: ER/PR+ or triple negative

BRE 224 CMC only

A single arm, preoperative, pilot study to evaluate the safety and biological effects of orally administered reparixin (CXCR1 inhibitor/cancer stem cell inhibitor) in early breast cancer patients who are candidates for surgery.

Adjuvant - Post surgery: HER2- positive

BRE 227

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

BRE 233

A Phase III Trial Comparing Chemotherapy Plus Trastuzumab Plus Pertuzumab Versus Chemotherapy Plus T-DM1 Plus Pertuzumab As Adjuvant Therapy In Patients With Operable HER2-Positive Primary Breast Cancer (KAITLIN)

Metastatic Breast Cancer: HER2 positive

BRE 208

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

1 prior chemo for MBC

BRE 203

A Phase II trial with TAK -700 (Androgen synthesis inhibitor) in Metastatic breast cancer patients with tumors that express the Androgen Receptor (AR)

BRE 230 DDU only

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

BRE 235 DDU only

A Phase 1b, open-label study to assess the safety and tolerability of ONT-380 (HER2-specific TKI) combined with capecitabine and trastuzumab, alone and in combination

BRE 240

A Phase 2a Study to Assess the Efficacy and Safety of Enzalutamide (AR inhibitor) with Trastuzumab in Subjects with HER2+ Metastatic or Locally Advanced Breast Cancer (AR+, ER-/PR-, HER2+ ; 2nd-5th line MBC)

BRE 245 selected clinics at TO

A Phase 2, randomized, safety and efficacy study of oral lucitanib (FGFR1,2,3 inhibitor) in patients with FGF aberrant metastatic breast cancer (FGFR 1 or 11q amplification required)

BRE 247 DDU only

A Phase 1b/2a Study of the Combination of KD019 (HER2 TKI) and Trastuzumab in Subjects with HER2-Positive Metastatic Breast Cancer

BRE 249

A Randomized Study of MM-302 (HER2-targeted liposomal doxorubicin) plus Trastuzumab vs. Chemotherapy of Physician’s Choice plus Trastuzumab in Anthracycline Naive Patients with Locally Advanced/Metastatic HER2-Positive Breast Cancer (HERMIONE

REFMAL 369 DDU only

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KTN3379 (Anti-HER3 antibody) in Combination with Chemotherapy in Adult Subjects with Advanced Tumors

CNS Metastases

BRE 200 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 DDU only

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

BRE 235 DDU only

A Phase 1b, open-label study to assess the safety and tolerability of ONT-380 (HER2-specific TKI) combined with capecitabine and trastuzumab, alone and in combination

BRE 247 DDU only

A Phase 1b/2a Study of the Combination of KD019 (HER2 TKI) and Trastuzumab in Subjects with HER2-Positive Metastatic Breast Cancer

ER+ and/or PR+/HER2-

BRE 226 DDU only

A phase Ib/II, multicenter, study of the combination of LEE011 (CDK 4/6 inhibitor) and BYL719 (PI3K inhibitor) with letrozole in adult patients with advanced ER+ breast cancer

BRE 229

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Efficacy and Safety of Enzalutamide (AR inhibitor) in Combination With Exemestane in Patients With Advanced Breast Cancer That Is ER/PR-Positive and HER2-Normal

BRE 239 DDU only

A Phase 1b Study of LY2835219 (CDK 4/6 inhibitor) in Combination with Endocrine Therapies for Patients with HR-Positive, HER2 Negative Metastatic Breast Cancer

REFMAL 275

Phase I, Dose-Escalation Study Evaluating GDC 0032 (PI3K inhibitor) In Pts With Locally Adv Or Metastatic Solid Tumors and In Combination With Endocrine Therapy In Pts With Locally Adv Or Metastatic HR+ Breast Cancer (WT and PIK3CA mutant permitted)

ER+ and/or PR+/HER2-

BRE 196 DDU only

A Phase 1 Study to assess the safety, tolerability, PK and preliminary efficacy of AZD2014 (TORC1/2 inhibitor) administered orally in combination with intramuscular (IM) Fulvestrant to Patients with Estrogen receptor (ER+) Advanced, MBC

BRE 212

Phase II open label study of everolimus (mTOR inhibitor) in combination with anti-estrogen therapy in HR-positive advanced breast cancer

BRE 226 DDU only

A phase Ib/II, multicenter, study of the combination of LEE011 (CDK 4/6 inhibitor) and BYL719 (PI3K inhibitor) with letrozole in adult patients with advanced ER+ breast cancer

BRE 229

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Efficacy and Safety of Enzalutamide (AR inhibitor) in Combination With Exemestane in Patients With Advanced Breast Cancer That Is ER/PR-Positive and HER2-Normal

BRE 239 DDU only

A Phase 1b Study of LY2835219 (CDK 4/6 inhibitor) in Combination with Endocrine Therapies for Patients with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

BRE 242

A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib (JAK1/2 inhibitor) or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer (1st-3rd line only)

BRE 196 DDU only

A Phase 1 Study to assess the safety, tolerability, PK and preliminary efficacy of AZD2014 (TORC1/2 inhibitor) administered orally in combination with intramuscular (IM) Fulvestrant to Patients with Estrogen receptor (ER+) Advanced, MBC

BRE 203

A Phase II trial with TAK -700 (Androgen synthesis inhibitor) in Metastatic breast cancer patients with tumors that express the Androgen Receptor (AR)

BRE 212

Phase II open label study of everolimus (mTOR inhibitor) in combination with anti-estrogen therapy in HR-positive advanced breast cancer

BRE 226 DDU only2

A phase Ib/II, multicenter, study of the combination of LEE011 (CDK 4/6 inhibitor) and BYL719 (PI3K alpha inhibitor) with letrozole in adult patients with advanced ER+ breast cancer

BRE 229

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Efficacy and Safety of Enzalutamide (AR inhibitor) in Combination With Exemestane in Patients With Advanced Breast Cancer That Is ER/PR-Positive and HER2-Normal

BRE 242

A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib (JAK1/2 inhibitor) or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer (1st-3rd line only)

BRE 243 DDU only

A phase Ib/II study of LEE011(CDK 4/6 inhibitor) in combination with fulvestrant and BYL719 (PI3K alpha inhibitor) or BKM120 (pan PI3K inhibitor) in the treatment of postmenopausal women with HR-positive, HER2 negative locally recurrent or advanced MBC

BRE 250 DDU only

Phase I Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumour Activity of Ascending Doses of AZD9496 (selective estrogen receptor down regulator) in Women with ER-Positive HER-2 Negative Advanced Breast Cancer

REFMAL 275

Phase I, Dose-Escalation Study Evaluating GDC 0032 (PI3K inhibitor) In Pts With Locally Adv Or Metastatic Solid Tumors and In Combination With Endocrine Therapy In Pts With Locally Adv Or Metastatic HR+ Breast Cancer (WT and PIK3CA mutant permitted)

BRE 203

A Phase II trial with TAK -700 (Androgen synthesis inhibitor) in Metastatic breast cancer patients with tumors that express the Androgen Receptor (AR)

BRE 225 DDU only

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

BRE 242

A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib (JAK1/2 inhibitor) or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer (1st-3rd line only)

BRE 243 DDU only

A phase Ib/II study of LEE011(CDK 4/6 inhibitor) in combination with fulvestrant and BYL719 (PI3K alpha inhibitor) or BKM120 (pan PI3K inhibitor) in the treatment of postmenopausal women with HR-positive, HER2 negative locally recurrent or advanced MBC

BRE 250 DDU only

Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD9496 (selective estrogen receptor down regulator) in Women with ER-Positive HER-2 Negative Advanced Breast Cancer

BRE 218

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

No prior chemo for MBC

BRE 242

A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib (JAK1/2 inhibitor) or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer (1st-3rd line only)

1 prior chemo for MBC

BRE 214

Phase 2 Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Pts with Relapsed /Refractory Advanced Breast Cancer Whose Tumors Express HER2 at 2+ Level by IHC and Lack Evidence of HER2 Gene Amplification by FISH

BRE 242

A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib (JAK1/2 inhibitor) or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer (1st-3rd line only)

BRE 245 selected clinics at TO

A Phase 2, randomized, safety and efficacy study of oral lucitanib (FGFR1,2,3 inhibitor) in patients with FGF aberrant metastatic breast cancer (FGFR 1 or 11q amplification required)

>2 prior chemo for MBC

BRE 214

Phase 2 Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Pts with Relapsed /Refractory Advanced Breast Cancer Whose Tumors Express HER2 at 2+ Level by IHC and Lack Evidence of HER2 Gene Amplification by FISH

BRE 242

A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib (JAK1/2 inhibitor) or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer (1st-3rd line only)

BRE 245

A Phase 2, randomized, safety and efficacy study of oral lucitanib (FGFR1,2,3 inhibitor) in patients with FGF aberrant metastatic breast cancer (FGFR 1 or 11q amplification required)

Triple negative- No prior chemo for MBC

BRE 223

A Phase 2/3, multi-center, open-label, randomized study of weekly nab-paclitaxel in combination with gemcitabine or carboplatin, compared to gemcitabine/carboplatin, as 1st-line treatment in subjects with ER, PR, and HER2 negative MBC (tnAcity)

BRE 245

A Phase 2, randomized, safety and efficacy study of oral lucitanib (FGFR1,2,3 inhibitor) in patients with FGF aberrant metastatic breast cancer (FGFR 1 or 11q amplification required)

BRE 231

A Randomized Multicenter Phase II Study of CDX-011 (CR011-vcMMAE ADC) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (METRIC)(1st-3rd line only)

BRE 242

A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib (JAK1/2 inhibitor) or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer (1st-3rd line only)

1 prior chemo for MBC

BRE 203

A Phase II trial with TAK -700 (Androgen synthesis inhibitor) in Metastatic breast cancer patients with tumors that express the Androgen Receptor (AR)

BRE 214

Phase 2 Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Pts with Relapsed /Refractory Advanced Breast Cancer Whose Tumors Express HER2 at 2+ Level by IHC and Lack Evidence of HER2 Gene Amplification by FISH

BRE 231

A Randomized Multicenter Phase II Study of CDX-011 (CR011-vcMMAE ADC) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (METRIC)(1st-3rd line only)

BRE 242

A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib (JAK1/2 inhibitor) or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer (1st-3rd line only)

BRE 245

A Phase 2, randomized, safety and efficacy study of oral lucitanib (FGFR1,2,3 inhibitor) in patients with FGF aberrant metastatic breast cancer (FGFR 1 or 11q amplification required)

>2 prior chemo for MBC

BRE 203

A Phase II trial with TAK -700 (Androgen synthesis inhibitor) in Metastatic breast cancer patients with tumors that express the Androgen Receptor (AR)

BRE 214

Phase 2 Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Pts with Relapsed /Refractory Advanced Breast Cancer Whose Tumors Express HER2 at 2+ Level by IHC and Lack Evidence of HER2 Gene Amplification by FISH

BRE 225 DDU only

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

BRE 231

A Randomized Multicenter Phase II Study of CDX-011 (CR011-vcMMAE ADC) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (METRIC) (1st-3rd line only)

BRE 242

A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib (JAK1/2 inhibitor) or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer (1st-3rd line only)

BRE 245 selected clinics at TO

A Phase 2, randomized, safety and efficacy study of oral lucitanib (FGFR1,2,3 inhibitor) in patients with FGF aberrant metastatic breast cancer (FGFR 1 or 11q amplification required)

REFMAL 264 DDU only

A Phase I, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of MPDL3280A (anti PD-L1 antibody) Administered Intravenously as a Single Agent to Patients with Locally Advanced or Metastatic Solid Tumors

Germline BRCA mutation
0-2 prior chemo for MBC (ER/PR+/ HER2- or triple negative)

BRE 236

Phase 3 Randomized Trial of Niraparib (PARP inhibitor) versus Physician’s Choice in Patients with Her2 Negative Germline BRCA Mutation and Previously-Treated Breast Cancer (BRAVO)

BRE 237

Phase 3, Randomized Study of BMN 673 (PARP inhibitor) vs Physician’s Choice in Germline BRCA Mutation Subjects with Locally Advanced and/or MBC, Who Have Received No More than 2 Prior Chemo Regimens for Metastatic Disease (EMBRACA)

> 1 prior chemo for MBC (ER/PR+/ HER2- or triple negative)

BRE 251 CMC only

A Phase 2, 2-Stage, 2-Cohort study of BMN 673 (PARP inhibitor) Administered to Germline BRCA Mutation Subjects with Locally advanced and/or Metastatic Breast Cancer (ABRAZO)

Refractory- ER/PR+/ HER2-

BRE 203

A Phase II trial with TAK -700 (Androgen synthesis inhibitor) in Metastatic breast cancer patients with tumors that express the Androgen Receptor (AR)

BRE 212

Phase II open label study of everolimus (mTOR inhibitor) in combination with anti-estrogen therapy in HR-positive advanced breast cancer

BRE 214

Phase 2 Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Pts with Relapsed /Refractory Advanced Breast Cancer Whose Tumors Express HER2 at 2+ Level by IHC and Lack Evidence of HER2 Gene Amplification by FISH

BRE 250 DDU only

Phase I Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumour Activity of Ascending Doses of AZD9496 (selective estrogen receptor down regulator) in Women with ER-Positive HER-2 Negative Advanced Breast Cancer

BRE 251 CMC only

A Phase 2, 2-Stage, 2-Cohort study of BMN 673 (PARP inhibitor) Administered to Germline BRCA Mutation Subjects with Locally advanced and/or Metastatic Breast Cancer (ABRAZO)

REFMAL 362 DDU only

A phase I/II study of CLR457 (PI3K α,β δ inh), administered orally in adult patients with advanced solid malignancies (PIK3CA mutation or amplification, PTEN loss of function, EGFR mutation, cMET activation and/or HER2 overexpression)

REFMAL 374 DDU only

A Phase 1b Study of ONT-10 (MUC1 targeting vaccine) and Varlilumab (CD27 antibody) in Patients with Advanced Ovarian Cancer or Breast Cancer

HER2 Positive

BRE 203

A Phase II trial with TAK -700 (Androgen synthesis inhibitor) in Metastatic breast cancer patients with tumors that express the Androgen Receptor (AR)

BRE 240

A Phase 2a Study to Assess the Efficacy and Safety of Enzalutamide (AR inhibitor) with Trastuzumab in Subjects with HER2+ Metastatic or Locally Advanced Breast Cancer (AR+, ER-/PR-, HER2+ ; 2nd-5th line MBC)

BRE 245 selected clinics at TO

A Phase 2, randomized, safety and efficacy study of oral lucitanib (FGFR1,2,3 inhibitor) in patients with FGF aberrant metastatic breast cancer (FGFR 1 or 11q amplification required)

BRE 247 DDU only

A Phase 1b/2a Study of the Combination of KD019 (HER2 TKI) and Trastuzumab in Subjects with HER2-Positive Metastatic Breast Cancer

REFMAL 362 DDU only

A phase I/II study of CLR457 (PI3K α,β δ inh), administered orally in adult patients with advanced solid malignancies (PIK3CA mutation or amplification, PTEN loss of function, EGFR mutation, cMET activation and/or HER2 overexpression)

REFMAL 369 DDU only

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KTN3379 (Anti-HER3 antibody) in Combination with Chemotherapy in Adult Subjects with Advanced Tumors

REFMAL 374 DDU only

A Phase 1b Study of ONT-10 (MUC1 targeting vaccine) and Varlilumab (CD27 antibody) in Patients with Advanced Ovarian Cancer or Breast Cancer

Triple negative

BRE 203

A Phase II trial with TAK -700 (Androgen synthesis inhibitor) in Metastatic breast cancer patients with tumors that express the Androgen Receptor (AR)

BRE 245 selected clinics at TO

A Phase 2, randomized, safety and efficacy study of oral lucitanib (FGFR1,2,3 inhibitor) in patients with FGF aberrant metastatic breast cancer (FGFR 1 or 11q amplification required)

BRE 251 CMC only

A Phase 2, 2-Stage, 2-Cohort study of BMN 673 (PARP inhibitor) Administered to Germline BRCA Mutation Subjects with Locally advanced and/or Metastatic Breast Cancer (ABRAZO)

REFMAL 264 DDU only

A Phase I, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of MPDL3280A (anti PD-L1 antibody) Administered Intravenously as a Single Agent to Patients with Locally Advanced or Metastatic Solid Tumors

BRE 230 DDU only

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

REFMAL 374 DDU only

A Phase 1b Study of ONT-10 (MUC1 targeting vaccine) and Varlilumab (CD27 antibody) in Patients with Advanced Ovarian Cancer or Breast Cancer

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