Randomized phase II trial of preoperative fulvestrant with or without enzalutamide in ER+/HER2- breast cancer
VIEW TRIAL ON CLINICALTRIALS.GOVBreast cancer, Hormone receptor positive breast cancer, locally advanced BC
Stage 2
Phase 2
Open to Enrollment
N/A
Enzalutamide and fulvestrant
Androgen receptor inhibitor
Greg Vidal, MD, PhD
University of Colorado, Department of Defense
ER positive, HER2 negative
Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)
VIEW TRIAL ON CLINICALTRIALS.GOVBreast, Triple Negative Breast Cancer
Stage 2
Phase 2
Open to Enrollment
Neoadjuvant
Neratinib
HER2 targeted small molecule
Greg Vidal, MD, PhD
West Cancer Center, Puma Biotechnology, Celcuity
ER negative, PR negative, HER2 negative
RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction
VIEW TRIAL ON CLINICALTRIALS.GOVBreast cancer
Stage 2
Phase 3
Open to Enrollment
Adjuvant
Hypofractionated radiotherapy
Radiation
Noam VanderWalde, MD
Alliance for Clinical Trials in Oncology
Invasive ductal, invasive lobular, tubular
A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
VIEW TRIAL ON CLINICALTRIALS.GOVBreast Cancer, Early Breast Cancer, Node-positive breast cancer
Stage 2
Phase 3
Open to Enrollment
Post-neoadjuvant
N/A
N/A
Richard Fine, MD
Alliance for Clinical Trials in Oncology
Node-positive any histology
Breast Cancer, Early Breast Cancer, Node-positive breast cancer
Stage 2
Phase 3
Open to enrollment
Post-neoadjuvant
regional nodal irradiation
N/A
Noam VanderWalde, MD
NSABP Foundation
Node positive prior to surgery, pathologically node negative at surgery
Patients must have pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma). Patients may not have had documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy).
Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant chemotherapy)
Hormone receptor status must be performed on the primary breast tumor before neoadjuvant chemotherapy.
HER2 status must be performed on the primary breast tumor before neoadjuvant chemotherapy. Patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible)
Patients must have completed a minimum of 8 weeks of standard neoadjuvant chemoterahyp consisting of an anthracycline and/or taxane-based regimen
For patients who receive adjuvant chemotherapy after surgery a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization
Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.
At the time of definitive surgery, all removed axillary nodes must be histologically free of cancer
ECOG PS 0-1
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
VIEW TRIAL ON CLINICALTRIALS.GOVBreast cancer
Stage 4
Phase 3
Open to Enrollment
1st line (pre-chemo)
GDC-9545
Selective estrogen receptor degrader (SERD)
Greg Vidal, MD, PhD
Hoffmann-LaRoche
ER+ (positive), HER2 - (negative)
A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
VIEW TRIAL ON CLINICALTRIALS.GOVBreast, Triple Negative Breast Cancer, TNBC
Stage 4
Phase 1
Open to Enrollment
2nd or 3rd line
MK-5890
CD27 agonist
Dan Vaena, MD
Merck Sharp & Dohme Corp
ER negative, PR negative, HER2 negative
An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2− Breast Cancer With an ESR1 Mutation
VIEW TRIAL ON CLINICALTRIALS.GOVBreast cancer, invasive breast cancer, BC, hormone receptor positive BC
Stage 4
Phase 2
Open to Enrollment
2nd Line or later endocrine tx
Lasofoxifene
SERM
Lee Schwartzberg, MD
Sermonix Pharmaceuticals LLC
ER positive, HER2 negative
A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC
VIEW TRIAL ON CLINICALTRIALS.GOVBreast cancer, triple-negative breast cancer, TNBC
Stage 4
Phase 2
Open to Enrollment
1st Line
Tesetaxel, nivolumab, pembrolizumab, atezolizumab
oral taxane, PD-1 or PD-L1 inhibitors
Lee Schwartzberg, MD
Odonate Therapeutics, Inc.
ER negative, PR negative, HER2 negative
A Phase 1b/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer
VIEW TRIAL ON CLINICALTRIALS.GOVBreast, Triple Negative Breast Cancer, TNBC
Stage 4
Phase 1
Open to Enrollment
2nd Line
Atezolizumab with Ipatasertib or ladiratuzumab-vidotin or Bevacizumab or Cobimetinib or Capecitabine or Combination Chemo
PD-L1 antibody with either PI3Ki or LIV1A ADC or MEKi or VEGFRi or chemo
Greg Vidal, MD, PhD
Hoffman-La Roche
ER- (negative), PR- (negative), HER2- (negative)
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm A: Entrectinib in patients with ROS1 fusion-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVBreast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Ideally 1st line, but can be later line as well
Entrectinib
TKI against NTRK, ROS, and ALK
Axel Grothey, MD
Genentech, Inc.
ROS1 fusion. Any cancer type except not NSCLC
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: ArmB: GDC-0077 in patients with PI3K activating mutation-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVBreast, Lung (NSCLC), Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Any line
GDC-0077
PI3K p110 alpha inhibitor
Axel Grothey, MD
Genentech, Inc.
PIK3CA mutation positive. Any malignancy except NOT CNS tumors
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: ArmC: Alectinib in patients with ALK rearrangement-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVBreast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Any line
Alectinib
ALK and RET inhibitor
Axel Grothey, MD
Genentech, Inc.
ALK rearrangement/fusion in any malignancy except not NSCLC
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVAny: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Any line
Ipatasertib
AKT inhibitor
Axel Grothey, MD
Genentech, Inc.
PTEN loss or loss of function
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVAny: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Any line
Ipatasertib
AKT inhibitor
Axel Grothey, MD
Genentech, Inc.
select AKT mutations
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression patterns predictive of response: Atezolizumab plus chemotherapy in patients with TMB-H/MSI-H/dMMR-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVAny: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Any line but cannot have previously had PD-1
Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)
PD-L1 inhibitor + chemotherapy
Axel Grothey, MD
Genentech, Inc.
TMB high, defined as > or = 10 mutations/megabase
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression patterns predictive of response: Atezolizumab plus chemotherapy in patients with TMB-H/MSI-H/dMMR-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVAny: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Any, but cannot have had prior anti-PD-1 or anti-PD-L1
Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)
PD-L1 inhibitor + chemotherapy
Axel Grothey, MD
Genentech, Inc.
MSI-h or dMMR
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
VIEW TRIAL ON CLINICALTRIALS.GOVSolid Tumors: Breast, Lung (NSCLC), Colon, Prostate, Bladder, Kidney, Esophagus, Stomach (Gastric), Liver (HCC), Cervical, Endometrial, Ovarian, Skin, Head and Neck (SCCHN), Bladder, Kidney (renal cell), Pancreatic, Rectal, Brain (GBM, glioblastoma)
Stage 4
Phase 2
Open to Enrollment
Following all effecive therapy (late line)
Pemigatinib
FGFR inhibitor
Dan Vaena, MD
Incyte Corporation
FGFR 1,2,3 mutated or FGFR 1,2,3 fusion/translocation
An open-label, multicenter, multinational, phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification
VIEW TRIAL ON CLINICALTRIALS.GOVBladder, Breast, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Melanoma, Ovarian, Endometrial (Uterine), Cervical, Gastric, Pancreatic, Hepatocellular (HCC), Esophageal, lymphoma, sarcoma
Stage 4
Phase 2
Open to Enrollment
Any (provided no curative therapy available)
Neratinib
pan-HER TKI
Lee Schwartzberg, MD
Puma Biotechnologies
HER2 (ERBB2) mutation or HER4 (ERBB4 mutation), or EGFR ex. 18 mutated lung cancer
A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
VIEW TRIAL ON CLINICALTRIALS.GOVColon, Ovarian, Gastric, Pancreatic, Endometrial, lung, prostate, breast
Stage 4
Phase 1
Open to Enrollment
Late line
OBI-888
Anti-globo-H antibody
Axel Grothey, MD
OBI Pharma
Globo-H overexpression
Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies
VIEW TRIAL ON CLINICALTRIALS.GOVLung, Breast, Colon, Pancreas, Bladder, Kidney, Prostate, Melanoma, Lymphoma, Gastric, Head and Neck (SCCHN)
Stage 4
Phase 1
Open to Enrollment
Any line as long as appropriate to give study acceptable chemo in combination
TTX-030
anti CD-39
Dan Vaena, MD
Trishula Therapeutics, Inc.
Any malignancy
A Phase 1a/1b study of COM701 as monotherapy and in combination with an anti-PD-1 antibody in subjects with advanced solid tumors.
VIEW TRIAL ON CLINICALTRIALS.GOVOvarian, uterine, endometrial, breast, TNBC, lung, colon, CRC, NSCLC, head and neck, SCCHN, gastric, stomach, kidney, renal, RCC, bladder, transitional cell,
Stage 4
Phase 1
Open to Enrollment
Late line
COM-701, PD(L)-1 antibody
PVRIG monoclonal antibody, PD(L)-1 antibody
Dan Vaena, MD
Compugen
A Phase 1/2 first-in-human study of BMS-986258 alone and in combination with nivolumab in advanced malignant tumors
VIEW TRIAL ON CLINICALTRIALS.GOVRenal cell (kidney), CRC (colon, rectal, colorectal), lung cancer (NSCLC), Head and Neck (SCCHN), Triple Negative Breast (TNBC)
Stage 4
Phase 1
Open to Enrollment
2nd line or greater
BMS 986258
TIM-3 antibody
Dan Vaena, MD
Bristol Myers Squibb
Lung- non-small cell; Breast- Triple Negative; RCC- clear cell; CRC- any; SCCHN- any