Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Romidepsin
Abraxane

Treatment (Romidepsin and Abraxane)

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0

Maximum-Tolerated Dose of Romidepsin (Phase I)

Progression-Free Survival (PFS)

Summary tables of grade 2, 3, and 4 toxicities, adverse events (AE), and serious adverse events (SAE) will be generated at the conclusion of the study as well as at the conclusion of phase I study and after 15 patients have been collected on at the interim evaluation time point of the phase 2 part of the study.

Incidence of Adverse Events, Graded According to NCI CTCAE Version 4.0

The 95% confidence intervals should be provided.

Overall Response Rate (ORR)

Clinical Benefit Rate (CBR)

Overall Study

Dr. Maysa Abu-Khalaf

HER2-negative Breast Cancer

Inflammatory Breast Cancer

Male Breast Cancer

Recurrent Breast Cancer

Stage IV Breast Cancer

Romidepsin

Abraxane

Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center

Thomas Jefferson University

Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer

A Phase I/II Study of Romidepsin in Combination With Abraxane in Patients With Metastatic Inflammatory Breast Cancer

Sidney Kimmel Cancer Center at Thomas Jefferson University

Celgene Corporation

PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide

Breast Cancer

2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.

Panitumumab

100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.

Nab-paclitaxel

AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.

Carboplatin

500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).

5-Fluorouracil

100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).

Epirubicin

500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).

Cyclophosphamide

University of Texas MD Anderson Cancer Center Website

University of Texas MD Anderson Cancer Center

Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer

Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression

Pathologic CR: No evidence of residual invasive tumor, including no residual tumor in the axillary lymph nodes.

M.D. Anderson Cancer Center

Amgen

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12, and then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.

Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11, and then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.

Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).

Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)

Received nP x 12 followed by ddAC x 6 without bevacizumab

Arm 2 (Nab-Paclitaxel / AC+PEG-G))

Received ddAC x 6 first followed by nP x 12, without bevacizumab

Arm 3 (AC+PEG-G / Nab-Paclitaxel)

Total

Race/Ethnicity, Customized

Inflammatory Breast Cancer (IBC) or Non-IBC Locally Advanced Breast Cancer (LABC)

Hormone receptor status

Measure Description: As per AJCC 6th ed, 2002:
https://cancerstaging.org/references-tools/deskreferences/Documents/AJCC6thEdCancerStagingManualPart2.pdf

Breast cancer stage

Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes.

Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))

Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab

Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))

Number of Patients With Pathological Complete Response Rate

Time from registration to death due to any cause

Arm II received nP x 12 followed by ddAC x 6, and those randomized to Arm III received ddAC x 6 first followed by nP x 12, both without bevacizumab

Overall Survival

Time from registration to first instance of any of the following events: progression prior to surgery, recurrence post-surgery or death from any cause.

Event-free Survival

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.

Arm II (Nab-Paclitaxel - AC+PEG-G)

Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.

Arm III (AC+PEG-G - Nab-Paclitaxel)

Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug

Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G))

Received nP x 12 without bevacizumab followed by ddAC x 6

Arm 2 (Nab-Paclitaxel / AC+PEG-G)

ddAC x 6 followed by nP x 12 without bevacizumab

Breast Committee Statistician

bevacizumab

pegfilgrastim

cyclophosphamide

doxorubicin hydrochloride

paclitaxel albumin-stabilized nanoparticle formulation

Providence Cancer Center at Providence Hospital

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Alta Bates Summit Comprehensive Cancer Center

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Peninsula Medical Center

East Bay Radiation Oncology Center

Valley Medical Oncology Consultants - Castro Valley

Valley Medical Oncology

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

USC/Norris Comprehensive Cancer Center and Hospital

Contra Costa Regional Medical Center

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

El Camino Hospital Cancer Center

Sutter Health - Western Division Cancer Research Group

Highland General Hospital

Alta Bates Summit Medical Center - Summit Campus

Bay Area Breast Surgeons, Incorporated

CCOP - Bay Area Tumor Institute

Larry G Strieff MD Medical Corporation

Tom K Lee, Incorporated

Epic Care - Oakland

St. Joseph Hospital Regional Cancer Center - Orange

Desert Regional Medical Center Comprehensive Cancer Center

Valley Medical Oncology Consultants - Pleasanton

University of California Davis Cancer Center

California Pacific Medical Center - California Campus

Doctors Medical Center - San Pablo Campus

Sutter Pacific Medical Foundation

Tahoe Forest Cancer Center

Sutter Solano Medical Center

San Luis Valley Regional Medical Center

University of Colorado Cancer Center at UC Health Sciences Center

Memorial Hospital Cancer Center - Colorado Springs

Shaw Regional Cancer Center

Valley View Hospital Cancer Center

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Montrose Memorial Hospital Cancer Center

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Tunnell Cancer Center at Beebe Medical Center

CCOP - Christiana Care Health Services

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

CCOP - Mount Sinai Medical Center

Phoebe Cancer Center at Phoebe Putney Memorial Hospital

Northeast Georgia Cancer Care, LLC - Medical Oncology

Piedmont Hospital

Northside Hospital Cancer Center

Saint Joseph's Hospital of Atlanta

CCOP - Atlanta Regional

MBCCOP - Medical College of Georgia Cancer Center

WellStar Cobb Hospital

John B. Amos Cancer Center

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Piedmont Fayette Hospital

Northeast Georgia Medical Center

Gwinnett Medical Center

Kennestone Cancer Center at Wellstar Kennestone Hospital

Southern Regional Medical Center

Harbin Clinic Cancer Center - Medical Oncology

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Kapiolani Medical Center at Pali Momi

Cancer Research Center of Hawaii

OnCare Hawaii, Incorporated - Lusitana

Queen's Cancer Institute at Queen's Medical Center

Straub Clinic and Hospital, Incorporated

Hawaii Medical Center - East

OnCare Hawaii, Incorporated - Kuakini

Kapiolani Medical Center for Women and Children

Castle Medical Center

Kauai Medical Clinic

Maui Memorial Medical Center

Pacific Cancer Institute - Maui

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

St. Joseph Regional Medical Center

Illinois CancerCare - Bloomington

St. Joseph Medical Center

Graham Hospital

Illinois CancerCare - Canton

Illinois CancerCare - Carthage

Memorial Hospital

Resurrection Medical Center

University of Chicago Cancer Research Center

Decatur Memorial Hospital Cancer Care Institute

Eureka Community Hospital

Illinois CancerCare - Eureka

Galesburg Clinic, PC

Illinois CancerCare - Galesburg

Illinois CancerCare - Havana

Mason District Hospital

Illinois CancerCare - Kewanee Clinic

Illinois CancerCare - Macomb

McDonough District Hospital

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Illinois CancerCare - Monmouth

OSF Holy Family Medical Center

BroMenn Regional Medical Center

Community Cancer Center

Illinois CancerCare - Community Cancer Center

S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer

A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A)and Cyclophosphamide (C) Plus Pegfilgrastim (PEG-G) as Neoadjuvant Therapy For Inflammatory and Locally Advanced HER-2/NEU Negative Breast Cancer

Southwest Oncology Group

National Cancer Institute (NCI)

Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians' judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.

Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT (Neoadjuvant chemotherapy). Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians' judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.

Neoadjuvant, Surgery, Adjuvant

Menopausal status

Phase II NCT (Neoadjuvant Chemotherapy) w/ Weekly Abraxane in Combination With Carboplatin & Bevacizumab in Breast Cancer

Phase II Trial of Neoadjuvant Chemotherapy [NCT] With Weekly Nanoparticle Albumin-bound Paclitaxel [Nab-paclitaxel; Abraxane®] in Combination With Carboplatin and Bevacizumab in Women With Clinical Stages I-III Breast Cancer

inflammatory breast neoplasms/albuminas

Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer

Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer

S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer

Phase II NCT (Neoadjuvant Chemotherapy) w/ Weekly Abraxane in Combination With Carboplatin & Bevacizumab in Breast Cancer

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