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Adriamycin and Cytoxan

Phase 2

Breast Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 25, 2019

Success Probability

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment197

FDA Designations

No designations recorded

Clinical trial landscape

Adriamycin and Cytoxan · 1 trial · 1 indication

Phase 2 1
NCT00394251Study of Dose-dense Adriamycin Plus Cytoxan (AC) Followed by Either ABI-007 (Abraxane) or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast CancerBreast Cancer
COMPLETED197 Analytics
PHASE2COMPLETED
Study of Dose-dense Adriamycin Plus Cytoxan (AC) Followed by Either ABI-007 (Abraxane) or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 3 Months Post Chemotherapy
Month 7

Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of \>=20% in any treatment arm, and participants with at least one toxicity are reported. Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 3 months after chemotherapy (month 7). Entire regiments (AC --\> ABI-007 and AC --\> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 3 months after chemotherapy (month 7).

Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 6 Months Post Chemotherapy
Month 10

Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of \>=20% in any treatment arm, and participants with at least one toxicity are reported. Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 6 months after chemotherapy (month 10). Entire regiments (AC --\> ABI-007 and AC --\> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 6 months after chemotherapy (month 10).

Secondary Endpoints

The Cumulative Dose of Taxane Delivered During Study
approximately week 9-16
Mean Taxane Dose Intensity Per Week
approximately week 9-16
Percent of Protocol Taxane Dose
approximately week 9-16
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AC --> ABI-007EXPERIMENTALAdriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m\^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
AC --> TaxolEXPERIMENTALAdriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m\^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).

Interventions

NameTypeDescription
Adriamycin and Cytoxan (AC)DRUGAdriamycin (doxorubicin) and Cytoxan (cyclophosphamide) make up the chemotherapy regimen known as AC. Adriamycin 60 mg/m\^2 intravenous, plus Cytoxan 600 mg/m\^2 intravenous on Day 1 of each of four 2-week cycles (weeks 1-8).
ABI-007DRUG260 mg/m\^2 IV on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)
TaxolDRUG175 mg/m\^2 intravenously (IV) on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)
BevacizumabDRUG10 mg/kg on day 1 of each of eight 2-week cycles (weeks 9-16), then 15 mg/kg on day 1 of each of ten three-week cycles (weeks 17-46).
pegfilgrastimDRUG6 mg subcutaneous (SC) on day 2 for each of the first four 2-week cycles (weeks 1-8). Pegfilgrastim 6 mg SC was administered on day 2 of cycles 6-8 (weeks 11-16) during taxane treatment only if necessary.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: A patient was eligible for inclusion in this study only if all of the following criteria were met: 1. Female, age greater than or equal to 18 to less than or equal to 70 years old. 2. Estrogen receptor (ER) and progesterone receptor (PR) status have been determined. 3. Operable...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
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Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
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GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Adriamycin and Cytoxan

What is Adriamycin and Cytoxan used for in breast cancer?

Adriamycin and Cytoxan is a combination of two chemotherapy drugs used in the treatment of breast cancer. It is being studied as adjuvant therapy, meaning it is given after primary treatment to reduce the risk of cancer recurrence. The combination is administered in a dose-dense schedule as part of a clinical trial.

Who makes Adriamycin and Cytoxan?

Adriamycin and Cytoxan is developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical research on this combination for the treatment of breast cancer.

What phase is Adriamycin and Cytoxan in?

Adriamycin and Cytoxan is in Phase 2 clinical development for breast cancer. It is an investigational combination and is not yet approved by regulatory authorities. The Phase 2 trial has been completed, with results informing further development.

What clinical trials is Adriamycin and Cytoxan in?

Adriamycin and Cytoxan was studied in a Phase 2 clinical trial with the identifier NCT00394251. This completed trial enrolled 197 female patients with breast cancer in the United States. The study evaluated dose-dense Adriamycin plus Cytoxan followed by either ABI-007 or Taxol with bevacizumab as adjuvant therapy.

Is Adriamycin and Cytoxan the same as AC?

Yes, Adriamycin and Cytoxan is commonly referred to as AC, which stands for the combination of Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide). This abbreviation is used in clinical settings and research to denote the two-drug regimen.