NCT00394251 is a Phase 2 clinical trial of Adriamycin and Cytoxan (AC) in Breast Cancer, sponsored by Celgene.

Who is sponsoring NCT00394251?

NCT00394251 is sponsored by Celgene.

What drugs are being tested in NCT00394251?

Interventions in NCT00394251: Adriamycin and Cytoxan (AC), ABI-007, Taxol, Bevacizumab, pegfilgrastim.

What condition does NCT00394251 study?

NCT00394251 studies Breast Cancer.

Is NCT00394251 still recruiting?

NCT00394251 is currently completed. Last updated 25 November 2019.

Are results published for NCT00394251?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-25 · How we verify

NCT00394251

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 25 November 2019

What this trial tests

Phase 2 trial testing Adriamycin and Cytoxan (AC) in Breast Cancer in 197 participants. Completed in 1 February 2008.

Timeline

1 August 2006

Primary endpoint
1 March 2007

1 February 2008

Quick facts

Lead sponsor	Celgene
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	197
Start date	1 August 2006
Primary completion	1 March 2007
Estimated completion	1 February 2008
Sites	27 locations across United States

Drugs / interventions tested

Adriamycin and Cytoxan (AC)
ABI-007
Taxol (Nabpaclitaxel) — full drug profile →
Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
pegfilgrastim (PEGFILGRASTIM) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Celgene — full company profile →

Who can join

Adults 18 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Cumulative Dose of Taxane Delivered During Study Secondary · approximately week 9-16

The cumulative dose of taxane (Taxol or ABI-007) taken during the study (cycles 4-8 which is approximately weeks 9-16).

Group	Value	95% CI
AC --> ABI-007	950.5	± 199.86
AC --> Taxol	660.8	± 99.52

Mean Taxane Dose Intensity Per Week Secondary · approximately week 9-16

Cumulative taxane (ABI-007 or Taxol) dose divided by the number of weeks on taxane treatment.

Group	Value	95% CI
AC --> ABI-007	118.82	± 24.983
AC --> Taxol	82.60	± 12.440

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

At least 1 AE at 3 Months

Group	Value	95% CI
ABI-007 Subset	65
AC --> ABI-007	74
Taxol Subset	65
AC --> Taxol	77

Neurology: Neuropathy: Sensory

Group	Value	95% CI
ABI-007 Subset	36
AC --> ABI-007	50
Taxol Subset	28
AC --> Taxol	35

Constitutional Symptoms: Fatigue

Group	Value	95% CI
ABI-007 Subset	16
AC --> ABI-007	46
Taxol Subset	10
AC --> Taxol	32

Dermatology/Skin: Hair Loss/Alopecia (Scalp+Body)

Group	Value	95% CI
ABI-007 Subset	2
AC --> ABI-007	33
Taxol Subset	1
AC --> Taxol	17

Endocrine: Hot Flashes/Flushes

Group	Value	95% CI
ABI-007 Subset	12
AC --> ABI-007	28
Taxol Subset	5
AC --> Taxol	22

Cardiac General: Hypertension

Group	Value	95% CI
ABI-007 Subset	4
AC --> ABI-007	18
Taxol Subset	7
AC --> Taxol	25

Pain: Arthralgia

Group	Value	95% CI
ABI-007 Subset	7
AC --> ABI-007	22
Taxol Subset	8
AC --> Taxol	19

Hemorrhage/Bleeding: Nasal

Group	Value	95% CI
ABI-007 Subset	11
AC --> ABI-007	19
Taxol Subset	10
AC --> Taxol	18

Percent of Protocol Taxane Dose Secondary · approximately week 9-16

Percent of the protocol-defined taxane (ABI-007 or Taxol) dose that was actually taken by study participants.

Group	Value	95% CI
AC --> ABI-007	91.40	± 19.218
AC --> Taxol	94.40	± 14.217

Summary of Participant Treatment Exposure, Dose Interruptions, Dose Reductions, and Dose Delays Secondary · up to Week 46

Counts of participants who * completed the protocol-defined treatment cycles, * had a dose interruption * had a dose reduction * had a dose delay. A dose delay refers to the delay of all interventions in the cycle. Dose modifications are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Use of pegfilgrastim is included in the summary.

Completed 4 cycles of Adriamycin/Cytoxan (AC)

Group	Value	95% CI
AC --> ABI-007	95
AC --> Taxol	95

Received pegfilgrastim for 4 cycles during AC

Group	Value	95% CI
AC --> ABI-007	95
AC --> Taxol	94

Completed 4 cycles of taxane

Group	Value	95% CI
AC --> ABI-007	82
AC --> Taxol	84

Completed 18 cycles of bevacizumab

Group	Value	95% CI
AC --> ABI-007	61
AC --> Taxol	61

One or more dose reduction: Adriamycin

Group	Value	95% CI
AC --> ABI-007	10
AC --> Taxol	6

One or more dose reduction: Cytoxan

Group	Value	95% CI
AC --> ABI-007	9
AC --> Taxol	5

One or more dose reduction: Taxane

Group	Value	95% CI
AC --> ABI-007	12
AC --> Taxol	16

One or more dose interruption: Adriamycin

Group	Value	95% CI
AC --> ABI-007	1
AC --> Taxol	0

Myelosuppression During Taxane Dosing Cycles Secondary · Weeks 9-16

Myelosuppression represented by neutropenia (low absolute neutrophil counts (ANC)) with severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE). * Grade 1 = \<lower limit of normal (LLN)-1.5\*10\^9/L * Grade 2 = \<1.5 - 1.0\*10\^9/L * Grade 3 = \<1.0 - 0.5\*10\^9/L * Grade 4 = \<0.5\*10\^9/L Values are reported across all severity grades without assessment of relationship to taxane treatment, and also by relation to taxane treatment as reported by investigators.

ANC (grades 1-4)

Group	Value	95% CI
AC --> ABI-007	58
AC --> Taxol	43

Taxane-related, grades 1-4

Group	Value	95% CI
AC --> ABI-007	11
AC --> Taxol	8

Taxane-related, grades 3-4

Group	Value	95% CI
AC --> ABI-007	6
AC --> Taxol	5

Change From Baseline in Percent Left Ventricular Ejection Fraction (% LVEF) at the Final Evaluation Secondary · up to week 46

Decreased left ventricular ejection fraction (LVEF) is an indication of cardiotoxicity. Change from baseline measurements to the final evaluation are summarized.

Group	Value	95% CI
AC --> ABI-007	-1.0	-30 – 16
AC --> Taxol	-1.0	-699 – 16

Summary of Participants' Most Severe Grade for Liver and Renal Function Laboratory Adverse Experiences During Study (All Treatment Cycles) Secondary · Week 1 up to week 50

Summary of the most severe grades using the National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (CTCAE) for the following liver and renal function tests. Grade 0 = within normal range for all measurements. Alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST): * Grade 1 = \> upper limit of normal (ULN) - 2.5\*ULN * Grade 2= \>2.5-5.0\*ULN * Grade 3= \>5.0-20.0\*ULN * Grade 4= \>20.0\*ULN Bilirubin: * Grade 1= \>ULN - 1.5\*ULN * Grade 3= \>3.0 - 10.0\*ULN Creatinine: \- Grade 1= \>ULN - 1.5\*ULN

Alkaline phosphatase, Grade 0

Group	Value	95% CI
AC --> ABI-007	69
AC --> Taxol	70

Alkaline phosphatase, Grade 1

Group	Value	95% CI
AC --> ABI-007	26
AC --> Taxol	29

Alkaline phosphatase, Grade 2

Group	Value	95% CI
AC --> ABI-007	1
AC --> Taxol	0

ALT, Grade 0

Group	Value	95% CI
AC --> ABI-007	66
AC --> Taxol	75

ALT, Grade 1

Group	Value	95% CI
AC --> ABI-007	24
AC --> Taxol	23

ALT, Grade 2

Group	Value	95% CI
AC --> ABI-007	5
AC --> Taxol	1

ALT, Grade 4

Group	Value	95% CI
AC --> ABI-007	1
AC --> Taxol	0

AST, grade 0

Group	Value	95% CI
AC --> ABI-007	74
AC --> Taxol	81

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

At least 1 AE at 6 Months

Group	Value	95% CI
ABI-007 Subset	49
AC --> ABI-007	62
Taxol Subset	46
AC --> Taxol	65

Neurology: Neuropathy: Sensory

Group	Value	95% CI
ABI-007 Subset	25
AC --> ABI-007	42
Taxol Subset	15
AC --> Taxol	19

Constitutional Symptoms: Fatigue

Group	Value	95% CI
ABI-007 Subset	11
AC --> ABI-007	32
Taxol Subset	4
AC --> Taxol	18

Endocrine: Hot Flashes/Flushes

Group	Value	95% CI
ABI-007 Subset	7
AC --> ABI-007	23
Taxol Subset	3
AC --> Taxol	17

Cardiac General: Hypertension

Group	Value	95% CI
ABI-007 Subset	4
AC --> ABI-007	12
Taxol Subset	7
AC --> Taxol	18

Pain: Arthralgia

Group	Value	95% CI
ABI-007 Subset	4
AC --> ABI-007	17
Taxol Subset	3
AC --> Taxol	13

Pain: Myalgia

Group	Value	95% CI
ABI-007 Subset	8
AC --> ABI-007	17
Taxol Subset	4
AC --> Taxol	8

Pain: Other - Extremity

Group	Value	95% CI
ABI-007 Subset	1
AC --> ABI-007	6
Taxol Subset	5
AC --> Taxol	14

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 - up to week 50 (weeks 1-46 treatment, plus 30 days after last study dose). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AC --> ABI-007

Serious: 30/98 (31%)

Deaths: —

AC --> Taxol

Serious: 21/99 (21%)

Deaths: —

Serious adverse events (49 terms)

Reaction	System	AC --> ABI-007	AC --> Taxol
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Cardiac failure congestive	Cardiac disorders	—	—
Chest pain	General disorders	—	—
Pyrexia	General disorders	—	—
Sepsis	Infections and infestations	—	—
Pancytopenia	Blood and lymphatic system disorders	—	—
Syncope	Nervous system disorders	—	—
Deep vein thrombosis	Vascular disorders	—	—
Appendicitis perforated	Gastrointestinal disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Coagulopathy	Blood and lymphatic system disorders	—	—
Colitis	Gastrointestinal disorders	—	—
Diverticulitis	Infections and infestations	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Hypertension	Vascular disorders	—	—
Hypotension	Vascular disorders	—	—
Ileus	Gastrointestinal disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Pericardial effusion	Cardiac disorders	—	—
Perirectal abscess	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Sinusitis	Infections and infestations	—	—
Wound infection	Infections and infestations	—	—

Other adverse events (105 terms — click to expand)

Reaction	System	AC --> ABI-007	AC --> Taxol
Fatigue	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Headache	Nervous system disorders	—	—
Neuropathy	Nervous system disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Mucosal inflammation	General disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Hot flush	Vascular disorders	—	—
Hypertension	Vascular disorders	—	—
Neuropathy peripheral	Nervous system disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Nail disorder	Skin and subcutaneous tissue disorders	—	—
Stomatitis	Gastrointestinal disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Insomnia	Psychiatric disorders	—	—
Anorexia	Metabolism and nutrition disorders	—	—
Pyrexia	General disorders	—	—
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Dysgeusia	Nervous system disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—
Dizziness	Nervous system disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—
Anxiety	Psychiatric disorders	—	—
Oedema peripheral	General disorders	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—
Leukopenia	Blood and lymphatic system disorders	—	—

Most-reported serious reactions: Febrile neutropenia, Cardiac failure congestive, Chest pain, Pyrexia, Sepsis, Pancytopenia, Syncope, Deep vein thrombosis.

Data from ClinicalTrials.gov NCT00394251 adverse events section.

Sponsor's own description

The primary objective of this study was to compare the safety of dose-dense ABI-007 (Abraxane) 260 mg/m\^2 or Taxol 175 mg/m\^2 given every 2 weeks following dose-dense Adriamycin plus Cytoxan (AC) chemotherapy. Bevacizumab was administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00394251 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 25 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00394251.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing