Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Hemangiosarcoma

Pathologic Complete Response

Breast Diseases

Skin Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Hypoglycemic Agents

Anti-Infective Agents

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Amino Acids

Trastuzumab

Paclitaxel

Cyclophosphamide

Carboplatin

Irinotecan

Doxorubicin

Liposomal doxorubicin

Pembrolizumab

Metformin

Letrozole

Albumin-Bound Paclitaxel

Immunomodulating Agents

Durvalumab

Olaparib

Cemiplimab

Dostarlimab

Neratinib

Pertuzumab

Ado-Trastuzumab Emtansine

Interferon-beta

Talazoparib

Tucatinib

Veliparib

SGN-LIV1A

Trebananib

Adenosine

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Topoisomerase I Inhibitors

Immunologic Factors

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Poly(ADP-ribose) Polymerase Inhibitors

Immunotoxins

Immunoconjugates

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Tyrosine

Paclitaxel, Herceptin followed by Doxorubicin and Cyclophosphamide treatment depending on HR/HER-2 status.

Novel Control Investigational Agent. Arm is closed.

Novel Investigational Agent. Arm is closed.

Novel investigational Agent followed by SOC

Novel investigational Agent followed by SOC. Arm is closed.

Paclitaxel: 80 mg/m2 IV during the 12 weekly treatment cycles post randomization; Doxorubicin: 60 mg/m2 IV after completion of the 12 weekly treatment cycles and prior to surgery for weeks 13-16; Cyclophosphamide: 600 mg/m2 IV after completion of the 12 weekly treatment cycles and prior to surgery for weeks 13-16

Standard Therapy

AMG 386 with or without Trastuzumab

AMG 479 (Ganitumab) plus Metformin

MK-2206 with or without Trastuzumab

AMG 386 and Trastuzumab

T-DM1 and Pertuzumab

Pertuzumab: 840 mg IV (loading dose) week 1 and 420 mg every 3 weeks (weeks 4, 7, 10) post-randomization; Trastuzumab: 4 mg/kg (loading dose) week 1 and 2 mg/kg weekly (weeks 2-12) post-randomization

Pertuzumab and Trastuzumab

Ganetespib

ABT-888

PLX3397

Pembrolizumab - 4 cycle

Talazoparib plus Irinotecan

Patritumab and Trastuzumab

Pembrolizumab - 8 cycle

Arm is closed. SGN-LIV1A: 2.5 mg/kg IV cycles 1,4,7,10 Doxorubicin + Cyclophosphamide: Cycles 13-16

Durvalumab plus Olaparib

Arm is closed. SD-101: IT injection 2 mg/ml (1 ml for T2 tumors, 2 ml for \>T3 tumors) weekly x 4, then every 3 weeks x 2 cycles 1,2,3,4,7,10 Pembrolizumab: 200mg IV cycles 1,4,7,10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles

SD-101 + Pembrolizumab

Arm is closed. Tucatinib: 300 mg PO BID 12 weeks CLOSED Tucatinib: 250 mg PO BID 12 weeks CLOSED Tucatinib adaptive: 150mg BID days 1-28, 250mg BID days 29-84 Trastuzumab: 4 mg/kg IV (loading dose) cycle 1; 2 mg/kg (thereafter) cycles 2-12 Pertuzumab: 840 mg IV (loading dose) cycle 1; 420 mg (thereafter) cycles 4, 7 and 10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles

Tucatinib plus trastuzumab and pertuzumab

Cemiplimab: 350 mg q3w X 12 weeks IV cycles 1,4,7,10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles

Cemiplimab: 350 mg q3w X 12 weeks IV cycles 1,4,7,10 REGN 3767: 1600 mg q3W X 12 weeks IV cycles 1,4,7,10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles

Cemiplimab plus REGN3767

Trilaciclib: 240 mg/m2 IV weekly cycle 1-16 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles

For HER2+:

Pertuzumab: 840 mg IV (loading dose) week 1 and 420 mg every 3 weeks (weeks 4, 7, 10) post-randomization Trastuzumab: 4 mg/kg (loading dose) week 1 and 2 mg/kg weekly (weeks 2-12) post-randomization

Trilaciclib with or without trastuzumab + pertuzumab

SYD985: 1.2 mg/kg IV (q3w x 12 weeks) cycles 1,4,7,10 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles

SYD985 ([vic-]trastuzumab duocarmazine)

For HER2+ Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Trastuzumab, 4 mg/kg cycle 1, then 2 mg/kg cycles 2-12 q1wk, IV, for wk1-12 Oral paclitaxel, 205 mg/m2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Carboplatin, AUC 1.5, IV, q1wk from wk1-12 Followed by Doxorubicin: 60 mg/m2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m2, IV, every 2 or 3 weeks for 4 cycle

For HER2- Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Oral paclitaxel, 205 mg/m2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Carboplatin, AUC 1.5, IV, q1wk from wk1-12 Followed by Doxorubicin: 60 mg/m2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m2, IV, every 2 or 3 weeks for 4 cycle

Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab

For HER2+ Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Trastuzumab, 4 mg/kg cycle 1, then 2 mg/kg cycles 2-12 q1wk, IV, for wk1-12 Oral paclitaxel, 205 mg/m2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Followed by Doxorubicin: 60 mg/m2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m2, IV, every 2 or 3 weeks for 4 cycle

For HER2- Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Oral paclitaxel, 205 mg/m2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Followed by Doxorubicin: 60 mg/m2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m2, IV, every 2 or 3 weeks for 4 cycle

Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab

Amcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks

Amcenestrant

Amcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks Abemaciclib (Verzenio), 150mg BID, p.o., for 24 weeks

Amcenestrant + Abemaciclib

Amcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks Letrozole (Femara), 2.5mg QD, p.o., for 24 weeks

Amcenestrant + Letrozole

ARX788

ARX788, 1.5 mg/kg Q3W, IV for 12 weeks Cemiplimab, 350 mg Q3W, IV for 12 weeks

ARX788 + Cemiplimab

VV1, 3x10\^9 TCID50 once (day-8), Intra-tumoral injection Cemiplimab, 350 mg Q3W, IV for 12 weeks

VV1 + Cemiplimab

Datopotamab deruxtecan

Dato-DXd, 6 mg/kg Q3W, IV for 12 weeks Durvalumab, 1120 mg Q3W, IV for 12 weeks

Datopotamab deruxtecan + Durvalumab

Zanidatamab: Flat dose of 1,200mg Q2W for 12 weeks

Zanidatamab

Lasofoxifene: 5.0 mg QD, p.o., for 24 weeks

Lasofoxifene

Z-endoxifen: 10 mg QD, p.o., for 24 weeks

Z-endoxifen

ARV-471

ARV-471: 200 mg QD, p.o, for 24 weeks Letrozole: 2.5 mg QD, p.o, for 24 weeks

ARV-471 + Letrozole

Won Chang

Maria Pitsiouni, PhD

Erica Stringer-Reasor, MD

Donald Northfelt, MD

Jennifer Tseng, MD

Anne Wallace, MD

Kristy Watkins, RN

Evanthia Roussos Torres, MD

Chaitali Nangia, MD

Amy Jo Chien, MD

Anthony Elias, MD

Trisha Burello, MS

Tara Snaft, MD

Lajos Pusztai, MD

Marlya Rozenblit, MD

Minetta Liu, MD

Claudine Isaacs, MD

Heather Han, MD

Kevin Kalinsky, MD

Rita Nanda, MD

Kathy S Albain, MD

Brittani Thomas, DO

Douglas Yee, MD

Judy C Boughey, MD

Coral Omene, MD, PhD

Jesus D Anampa

Yannis Karamitas

Nancy Chan, MD

Meghana Trivedi, MD

Carla Folksm, MD

Angela Howell, MD

Alexandra Thomas, MD

Taylor Knapp

Alexandra Zimmer, MD

Amy Clark, MD

Amy Sanford, MD

Laura Esserman, MD, MBA

The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.

I-SPY2 will assess the efficacy of novel drugs in sequence with standard chemotherapy. The goal is identify treatment strategies for subsets on the basis of molecular characteristics (biomarker signatures) of their disease with high estimated pCR rate. As described for previous adaptive trials, novel regimens with sufficiently high activities alone and contribute to treatment strategies that show a high Bayesian predictive probability of being more effective than the dynamic control will graduate from the trial with their corresponding biomarker signature(s). Treatment strategies will be dropped if they show a low probability of improved efficacy with any biomarker signature. New drugs will enter as those that have undergone testing complete their evaluation.

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)

QuantumLeap Healthcare Collaborative

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Urinary Bladder Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cone-beam CT images as well as MRI scans will be used to make any changes to the radiation treatment plan, part of the way through the treatment. Adaptation of treatment plans may allow smaller target volumes to be treated with higher doses, while minimizing the side effects to surrounding organs.

Adaptive Radiation Therapy

Peter Chung, MD

Radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. However, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. For prostate cancer patients, the risk is further amplified when pelvic nodes are part of the target irradiated volume. For bladder cancer patients, the risk of injury increases when more of the bladder is part of the target volume. Using an adaptive radiation therapy approach allows for correcting any shifts in the target volume. ART approach uses images from treatment to adapt the treatment plan. This study will use Adaptive Radiation Therapy for patients who receive pelvic nodal radiotherapy for either prostate or bladder cancer. Their treatment plans will adapted using MRI scans and CBCT scans taken during their first week of radiotherapy to account for any shifts in the target volume. The purpose of this study is to evaluate the feasibility of ART approach and its and on treatment plan quality metrics for pelvic radiotherapy. Acute and late toxicities will also be evaluated. 40 participants (minimum of 10 bladder cancer patients) will be enrolled. The participants will be followed for a period of 5 years post radiation therapy, during which they will have PSA as per standard practice, along with follow-up questionnaires (EPIC for prostate cancer patients and BUSS for bladder cancer patients).

A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer

Difference in dose-volume irradiation of critical organs between original and adapted plan will be compared.

To determine a preliminary measure of toxicity with this technique. CTCAE toxicity data will be described for this population.

Bladder Utility Symptom Scale (BUSS) questionnaires will be scored and analyzed to determine QoL function. BUSS will be scored (1-100) as per standard criteria. Data will be analyzed as a continuous variable

Expanded Prostate Cancer Index Composite (EPIC) questionnaires will be scored and analyzed to determine QoL function. EPIC will be scored (1-100) as per standard criteria. Data will be analyzed as a continuous variable

For prostate patients, patients will be considered to have biochemical failure if the PSA has risen 2ng above nadir.

Local control will be defined by an absence of clinically locally recurrent disease

Feasibility will be determined by analyzing the quality of target delineation using fiducial markers in bladder cancer patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer	NCT01042379	Breast Neoplasm... Breast Cancer Breast Tumors Angiosarcoma TNBC - Triple-N... HER2-positive B... HER2-negative B... Hormone Recepto... Hormone Recepto... Early-stage Bre... Locally Advance...	Standard Therap... AMG 386 with or... AMG 479 (Ganitu... MK-2206 with or... AMG 386 and Tra... T-DM1 and Pertu... Pertuzumab and ... Ganetespib ABT-888 Neratinib PLX3397 Pembrolizumab -... Talazoparib plu... Patritumab and ... Pembrolizumab -... SGN-LIV1A Durvalumab plus... SD-101 + Pembro... Tucatinib plus ... Cemiplimab Cemiplimab plus... Trilaciclib wit... SYD985 ([vic-]t... Oral Paclitaxel... Oral Paclitaxel... Amcenestrant Amcenestrant + ... Amcenestrant + ... ARX788 ARX788 + Cemipl... VV1 + Cemiplima... Datopotamab der... Datopotamab der... Zanidatamab Lasofoxifene Z-endoxifen ARV-471 ARV-471 + Letro...	18 Years -	QuantumLeap Healthcare Collaborative
A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer	NCT03909893	Prostate Cancer Bladder Cancer	Adaptive Radiat...	18 Years -	University Health Network, Toronto
A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer	NCT03909893	Prostate Cancer Bladder Cancer	Adaptive Radiat...	18 Years -	University Health Network, Toronto
InGReS: Intra-treatment Image Guided Adaptive Radiotherapy Dose-escalation Study	NCT05393297	Head and Neck C...	Imaging: Intra-... Intra-treatment...	18 Years -	Guy's and St Thomas' NHS Foundation Trust
Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer	NCT01142102	Bladder Cancer	Radiation Thera...	18 Years -	Trans Tasman Radiation Oncology Group

Spots Global Cancer Trial Database for adaptive

Every month we try and update this database with for adaptive cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for adaptive

Every month we try and update this database with for adaptive cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for adaptive cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.