Alliance Foundation Trials, LLC (AFT)

Alliance Foundation Trials, LLC (AFT) is a research organization that develops and conducts cancer clinical trials, working closely with the Alliance for Clinical Trials in Oncology scientific investigators and institutional member network, research collaborators, and non-NCI funding sources. AFT seeks to fulfill the vision of the Alliance for Clinical Trials in Oncology to reduce the impact of cancer on people by uniting a broad community of scientists and clinicians from many disciplines committed to discovering, validating and disseminating effective strategies for the prevention and treatment of cancer. Established in 2014 as a limited liability corporation, AFT is the sole member of the Alliance for Clinical Trials in Oncology Foundation. Current AFT studies are funded by a number of pharmaceutical company collaborators and the Patient-Centered Outcomes Research Institute (PCORI). For more information about developing an AFT study, contact the AFT Project Manager at or visit

Active AFT Trials
Select from the links below to learn more about specific AFT trials that are currently recruiting participants. 

AFT-05 | Breast Cancer
Palbociclib collaborative adjuvant study: A randomized phase 3 trial of palbociclib with adjuvant endocrine therapy versus endocrine therapy alone for hormone receptor positive/HER2-negative breast cancer
AFT PI: Erica Mayer, MD
Phase: Phase III
Opened: 08/26/2015

A phase 1 dose escalation and phase 2 randomized, placebo-controlled study of the efficacy and tolerability of veliparib in combination with paclitaxel/carboplatin-based chemoradiotherapy followed by veliparib and paclitaxel/carboplatin consolidation in subjects with stage III non-small cell lung cancer (NSCLC)
AFT PI: J. Salama and T. Stinchcombe
Phase: Phase I/II
Opened: 8/4/16

A phase I, open-label, multi-center trial of oral azacitidine (CC-486) plus R-CHOP in subjects with high risk (IPI 3 or more) previously
untreated diffuse large B-cell lymphoma or grade 3B follicular lymphoma

AFT PI: P. Martin
Phase: Phase I
Opened: 2/28/17

AFT-09/Pembrolizumab | Lung Cancer
A randomized phase II trial evaluating the optimal sequencing of PD-1 inhibition with pembrolizumab (MK-3475) and standard platinum-based chemotherapy in patients with chemotherapy naive stage IV non-small cell lung cancer
AFT PI: Thomas Hensing, MD
Phase: Phase II
Opened: 03/1/16

AFT-16 | Lung Cancer
Phase II trial of induction immunotherapy with anti-PD-L1 for PD-L1 positive patients with unresectable stage IIIA and IIIB
NSCLC eligible for chemoradiotherapy with curative intent

AFT PI: Helen J. Ross, MD
Phase: Phase II
Opened: 11/1/17

AFT-19/PRESTO | Prostate Cancer
A phase 3 study of androgen annihilation in high-risk biochemically relapsed prostate cancer
AFT PI: Rahul Aggarwal, MD
Phase: Phase III
Opened: 2/28/17

AFT-25 | Ductal Carcinoma in Situ (DCIS)
Comparison of operative to monitoring and endocrine therapy (COMET) trial for low risk DCIS: A phase III prospective randomized trial
AFT PI: E. Shelley Hwang MD, MPH
Phase: Phase III prospective randomized trial
Opened: 2/22/17

A study comparing atezolizumab (anti PD-L1 antibody) in combination with adjuvant anthracycline/taxane-based chemotherapy versus chemotherapy alone in patients with operable triple-negative breast cancer (IMpassion030)
AFT PI: H. McArthur
Phase: Phase III
Opened: 5/1/18

AFT-28 | Randomized Effectiveness
The benefits, harms and burdens of DOAC versus LMWH +/- warfarin for venous blood clots in cancer: A pragmatic randomized trial (CANVAS trial)
AFT PIDeborah Schrag, MD and Jean Connors, MD
Phase: N/A
Opened: 11/7/16

Phase 2, randomized, open-label study comparing daratumumab, lenalidomide, bortezomib, and dexamethasone (D-RVd) versus
lenalidomide, bortezomib, and dexamethasone (RVd) in subjects with newly diagnosed multiple myeloma eligible for high-dose
chemotherapy and autologous stem cell transplantation

AFT PI: P. Voorhees
Phase: Phase II
Opened: 8/29/16

AFT-32 | Mantle Cell Lymphoma
A phase II study of palbociclib in combination with ibrutinib in patients with previously treated mantle cell lymphoma
AFT PI: Kami Maddocks, MD
Phase: Phase II
Opened: 9/6/18

AFT-38 | Breast Cancer
A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy vs. anti-HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive (HR+)/HER2-positive metastatic breast cancer
AFT PI: Otto Metzer, MD
Phase: Phase III
Opened: 7/11/17

Electronic patient reporting of symptoms during cancer treatment (PRO-TECT) - (randomized effectiveness trial)
AFT PI: E. Basch
Phase: N/A
Opened: 10/4/17

Pending Activation

AFT-15 | Multiple Myeloma
A phase I/II study of ibrutinib (PCI-32765) in combination with revlimid/dexamethasone (Rd) in relapsed/refractory multiple myeloma
AFT PI: Yvonne A Efebera, MD MPH and Jacob P. Laubach, MD
Phase: Phase I/II

AFT-41 | Multiple Myeloma
A phase II study of lenalidomide, ixazomib, dexamethasone, and daratumumab in transplant-ineligible patients with newly diagnosed multiple myeloma
AFT PI: Elizabeth K. O’Donnell, MD
Phase: Phase II

AFT-42 | Lung Cancer/ Autoimmune
Safety, activity and pharmacology of nivolumab in patients with advanced non-small cell lung cancer and pre-existing autoimmune disease
AFT PI: Rebecca S. Heist, MD MPH
Phase: Phase I/II

AFT-46 | Lung Cancer
CHIO3 Trial: Chemotherapy combined with immune checkpoint inhibitor for operable stage IIIA/B non-small cell lung cancer
AFT PI: L. Martin, MD and J. Patel, MD
Phase: Phase III

AFT-47 |
ARACOG: Phase II study of androgen receptor and cognitive function in patients treated with darolutamide or enzalutamide
AFT PI: C. Ryan, MD and A. Morgans, MD
Phase: Phase II

ICARE data |
Integrating clinical trials and real-world endpoints, in collaboration with the MITRE Corporation
AFT PI: M. Fairweather, MD
Phase: N/A

AFT Trials In Development

AFT-35 | Multiple Myeloma
Phase I/II multicenter, open-label, dose-escalation study of the combination of pomalidomide, bortezomib, low-dose dexamethasone, and daratumumab, in patients with relapsed or refractory multiple myeloma
AFT PI: Hani Hassoun, MD
Phase: Phase I/II

AFT-49 | Multiple Myeloma
Randomized trial of consolidation targeted adjuvant therapy with encorafenib, binimetinib, and cetuximab versus usual care for patients with stage III V600E colon cancer
AFT PI: R. Yaeger, MD
Phase: Phase III