Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by ixabepilone at 40 mg/m2 given for 4 cycles of 21 days each.

Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by paclitaxel at 80 mg/m2 weekly for 12 weeks.

Ixabepilone (Ixempra)

Paclitaxel (Taxol)

Denise A Yardley, M.D.

This is a randomized, Phase III, open-label, multicenter study.

Patients will be randomized in a 1:1 ratio to receive one of two different treatment arms. Patients in treatment arm 1 will receive AC followed by ixabepilone. Patients in treatment arm 2 will receive AC followed by weekly paclitaxel.

A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer

Phase III Study of Doxorubicin/Cyclophosphamide (AC) Followed by Ixabepilone vs. AC Followed by Paclitaxel in Patients With Triple-Negative Early-Stage Breast Cancer

The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause.

The percentage of participants with overall survival at 3 and 5 years are presented. Overall survival (OS) defined as the time between randomization to date of death from any cause.

Bristol-Myers Squibb

SCRI Development Innovations, LLC

Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.

Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.

Doxorubicin: 60 mg/m2

Cyclophosphamide: 600 mg/m2

Ixabepilone (Ixempra): 40 mg/m2

Ixabepilone

Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.

Doxorubicin: 60 mg/m2

Cyclophosphamide: 600 mg/m2

Paclitaxel (Taxol): 80 mg/m2

Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel weekly for 12 weeks.

Doxorubicin: 60 mg/m2

Cyclophosphamide: 600 mg/m2

Paclitaxel (Taxol): 80 mg/m2

Total

<50 years

≥50 years

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Premenopausal

Postmenopausal

Menopausal Status

Analyses of baseline characteristics, demographics and efficacy includes all randomized patients.

Charles H. Davis, RAC

3-year DFS

5-year DFS

The intent-to-treat population (all randomized patients) are included in the analysis.

Disease-free Survival

3-year OS

5-year OS

Overall Survival

Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by ixabepilone every 3 weeks for 4 cycles (12 weeks).

Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Ixabepilone (Ixempra): 40 mg/m2

AC/Ixabepilone

Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by weekly paclitaxel for 12 weeks.

Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Paclitaxel (Taxol): 80 mg/m2

AC/Paclitaxel

AC Therapy

Adjuvant Therapy

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Androgens

Hormones

Hormone Antagonists

Participants will receive apalutamide 240 milligram (mg) (4X 60 mg tablets) with ADT.

Participants will receive matching Placebo with ADT.

Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.

Apalutamide

Participants will receive Placebo orally once daily in each 28 day treatment cycles.

Placebo

All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.

Androgen Deprivation Therapy (ADT)

Janssen Research & Development, LLC Clinical Trial

The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.

This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, multinational, multicenter study of apalutamide in participants with mHSPC. The study consists of 4 Phases: Screening Phase (up to 28 days before randomization), Treatment Phase (28 day treatment cycles until disease progression or the occurrence of unacceptable treatment related toxicity), an End of Treatment Phase (until 30 days after the last dose of study drug), and then a Survival Follow up Phase. In the event of a positive study result and notification of unblinding at either of the interim analyses or at the final analysis, participants in the treatment Phase will have the opportunity to enroll in an Open-label Extension Phase, which will allow participants to receive active drug (apalutamide) for approximately 3 years. Participants who are receiving apalutamide in the Open-label Extension Phase may continue receiving apalutamide in the Long-term Extension (LTE) Phase if they will continue to derive benefit from treatment (based on investigator assessment). Participants' safety will be monitored throughout the study.

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

rPFS as assessed by the investigator was defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurred first. Radiographic progressive disease was defined as progression of soft tissue lesions measured by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by modified Response evaluation criteria in solid tumors (RECIST) 1.1.

OS was defined as the time from date of randomization to date of death from any cause.

Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.

Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (\>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (\>=) 3 weeks apart or initiation of chronic opioids, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3 (worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.

Time to chronic opioid use was defined as the time from date of randomization to the first date of confirmed chronic opioid use. For participants entering the study without receiving opioids, chronic opioid use was defined as administration of opioid analgesics lasting for greater than or equal to (\>=) 3 weeks for oral or \>=7 days for non-oral formulations. For participants entering the study already receiving opioids, chronic opioid use was defined as a \>=30 percent (%) increase in total daily dose of the opioid analgesics lasting for \>= 3 weeks for oral or \>= 7 days for non-oral formulation.

Time to SRE was defined as the time from the date of randomization to the date of the first observation of an SRE. A SRE was defined as the occurrence of either a pathological fracture, or spinal cord compression, or radiation to bone, or surgery to bone.

Aragon Pharmaceuticals, Inc.

Safety Analysis set included all participants who received at least 1 dose of randomized study drug. Crossover participants were counted twice (in Placebo + ADT arm and in Placebo + ADT to Apalutamide + ADT arm) for safety analysis. For crossover participants, adverse events after initiation of crossover treatment were summarized separately in Placebo + ADT to Apalutamide + ADT arm. However, adverse events occurred before crossover treatment were summarized in Placebo + ADT arm.

Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.

Placebo + Androgen Deprivation Therapy (ADT)

After interim analysis and unblinding, participants receiving placebo +ADT crossed over to receive 240 mg apalutamide orally qd along with ADT in open-label extension phase.

Placebo + ADT to Apalutamide + ADT

Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.

Apalutamide + ADT

Age, Continuous

ARGENTINA

AUSTRALIA

BRAZIL

CANADA

CHINA

CZECH REPUBLIC

FRANCE

GERMANY

HUNGARY

ISRAEL

ITALY

JAPAN

MEXICO

POLAND

ROMANIA

RUSSIAN FEDERATION

SOUTH KOREA

SPAIN

SWEDEN

TURKEY

UKRAINE

UNITED KINGDOM

UNITED STATES

Region of Enrollment

American Indian or Alaska Native

Asian

Black or African American

More than one race

Not Reported

Other

White

Executive Medical Director

Intent to treat (ITT) population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.

Radiographic Progression-free Survival (rPFS)

ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer	NCT00789581	Breast Cancer	Doxorubicin Cyclophosphamid... Ixabepilone (Ix... Paclitaxel (Tax...	18 Years -	SCRI Development Innovations, LLC
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC	NCT02489318	Prostate Cancer	Apalutamide Placebo Androgen Depriv...	18 Years -	Aragon Pharmaceuticals, Inc.
A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer	NCT00789581	Breast Cancer	Doxorubicin Cyclophosphamid... Ixabepilone (Ix... Paclitaxel (Tax...	18 Years -	SCRI Development Innovations, LLC
TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy	NCT04596033	Melanoma Non-small Cell ... Squamous Cell C... Urothelial Carc... Renal Cell Carc... Small-cell Lung... Cutaneous Squam... Anal Squamous C... Merkel Cell Car...	GEN-011 IL-2 Fludarabine Cyclophosphamid...	18 Years -	Genocea Biosciences, Inc.

Spots Global Cancer Trial Database for titan

Every month we try and update this database with for titan 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 titan

Every month we try and update this database with for titan 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 titan 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.