NCT00281528 is a Phase 2 clinical trial of ABI-007 (Abraxane) in Breast Neoplasms, sponsored by Celgene.

Who is sponsoring NCT00281528?

NCT00281528 is sponsored by Celgene.

What drugs are being tested in NCT00281528?

Interventions in NCT00281528: ABI-007 (Abraxane), bevacizumab.

What condition does NCT00281528 study?

NCT00281528 studies Breast Neoplasms, Neoplasm Metastasis.

Is NCT00281528 still recruiting?

NCT00281528 is currently terminated. Last updated 22 November 2019.

Are results published for NCT00281528?

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

Last reviewed 2019-11-22 · How we verify

NCT00281528

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

Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer

Terminated Phase 2 Results posted Last updated 22 November 2019

What this trial tests

Phase 2 trial testing ABI-007 (Abraxane) in Breast Neoplasms in 208 participants. Terminated before completion.

Timeline

1 February 2006

Primary endpoint
1 July 2010

1 March 2011

Quick facts

Lead sponsor	Celgene
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	208
Start date	1 February 2006
Primary completion	1 July 2010
Estimated completion	1 March 2011
Sites	40 locations across Puerto Rico, United States

Drugs / interventions tested

ABI-007 (Abraxane) — full drug profile →
bevacizumab (Bevacizumab-Bvzr) — full drug profile →

Conditions studied

Breast Neoplasms — all drugs for Breast Neoplasms →
Neoplasm Metastasis — all drugs for Neoplasm Metastasis →

Sponsor

Celgene — full company profile →

Who can join

18 and older, female only, with Breast Neoplasms or Neoplasm Metastasis. 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 Percentage of Participants Confirmed Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0) Primary · Up to 43 months

Using the RECIST response criteria version 1.0, the percent of participants achieving either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	41
260 mg/m^2 ABI-007 Every 2 Weeks	43
130 mg/m^2 ABI-007 Weekly	47

Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response (i.e., Total Response) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0) Secondary · Up to 43 months (until progressed)

Using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), the percentage of participants achieving either * A complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or * A partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions or * Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for progressive disease.

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	65
260 mg/m^2 ABI-007 Every 2 Weeks	52
130 mg/m^2 ABI-007 Weekly	58

Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3) Primary · up to 54 months

Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) ANC counts were graded using NCI CTCAE version 3: Grade 0 = within normal limits; Grade 1 = \< lower limit of normal - 75.0\*10\^9L; Grade 2 = \<1.5 - 1.0\*10\^9L; Grade 3 = \<1.0 - 0.5\*10\^9L; Grade 4 = \<0.5\*10\^9L

Grade 0

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	51	± 1.569
260 mg/m^2 ABI-007 Every 2 Weeks	34	± 3.216
130 mg/m^2 ABI-007 Weekly	17	± .750

Grade 1

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	5
260 mg/m^2 ABI-007 Every 2 Weeks	5
130 mg/m^2 ABI-007 Weekly	17

Grade 2

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	2
260 mg/m^2 ABI-007 Every 2 Weeks	6
130 mg/m^2 ABI-007 Weekly	17

Grade 3

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	3
260 mg/m^2 ABI-007 Every 2 Weeks	4
130 mg/m^2 ABI-007 Weekly	17

Grade 4

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	2
260 mg/m^2 ABI-007 Every 2 Weeks	0
130 mg/m^2 ABI-007 Weekly	2

Kaplan Meier Estimate for Time to Disease Progression (TTP) Secondary · Up to 43 months (until progressed)

Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	8.0	7.0 – 10.3
260 mg/m^2 ABI-007 Every 2 Weeks	6.3	5.3 – 8.0
130 mg/m^2 ABI-007 Weekly	9.0	7.2 – 11.1

Kaplan Meier Estimate for Duration of Response Secondary · Up to 43 months (until progressed)

Duration of response was defined as the time from response to the time of disease progression for participants who achieve an objective confirmed complete (CR) or partial overall response (PR). Disease progression is based on the assessments by the investigator. Participants who did not have disease progression following a confirmed complete or partial target response were censored at the last known time that the participant was evaluated for response

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	10.3	8.0 – 12.3
260 mg/m^2 ABI-007 Every 2 Weeks	8.0	5.5 – 13.4
130 mg/m^2 ABI-007 Weekly	9.9	7.7 – 15.7

Kaplan Meier Estimate for Participant Survival Secondary · Up to 56 months

Participant survival was summarized using Kaplan-Meier estimate of the time of first dose of study drug to the last known time that the participant was alive. Participants that were alive at the end of follow-up would be censored at the last known time that the patient was alive.

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	21.3	19.5 – 26.6
260 mg/m^2 ABI-007 Every 2 Weeks	19.0	15.0 – 28.1
130 mg/m^2 ABI-007 Weekly	23.7	18.2 – 31.0

Participant Counts of the Most Severe Grade for White Blood Cells (WBC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3) Primary · up to 54 months

Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) WBC counts were graded using NCI CTCAE version 3: Grade 0 = within normal limits; Grade 1 = \< lower limit of normal -3.0\*10\^9/L; Grade 2 = \<3.0 - 2.0\*10\^9/L; Grade 3 = \<2.0 - 1.0\*10\^9/L; Grade 4 = \<1.0\*10\^9/L

Grade 0

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	47
260 mg/m^2 ABI-007 Every 2 Weeks	30
130 mg/m^2 ABI-007 Weekly	11

Grade 1

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	9
260 mg/m^2 ABI-007 Every 2 Weeks	14
130 mg/m^2 ABI-007 Weekly	21

Grade 2

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	6
260 mg/m^2 ABI-007 Every 2 Weeks	5
130 mg/m^2 ABI-007 Weekly	26

Grade 3

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	2
260 mg/m^2 ABI-007 Every 2 Weeks	0
130 mg/m^2 ABI-007 Weekly	11

Grade 4

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	0
260 mg/m^2 ABI-007 Every 2 Weeks	0
130 mg/m^2 ABI-007 Weekly	1

Participant Counts of the Most Severe Grade for Platelet Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3) Primary · up to 54 months

Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) platelet counts were graded using NCI CTCAE version 3: Grade 0 = within normal limits; Grade 1 = \< lower limit of normal - 75.0\*10\^9/L; Grade 2 = \<75.0 - 50.0\*10\^9/L; Grade 3 = \<50.0 - 25.0\*10\^9/L; Grade 4 = \<25.0\*10\^9/L

Grade 0

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	60
260 mg/m^2 ABI-007 Every 2 Weeks	39
130 mg/m^2 ABI-007 Weekly	64

Grade 1

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	2
260 mg/m^2 ABI-007 Every 2 Weeks	10
130 mg/m^2 ABI-007 Weekly	4

Grade 2

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	1
260 mg/m^2 ABI-007 Every 2 Weeks	0
130 mg/m^2 ABI-007 Weekly	1

Grade 3

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	0
260 mg/m^2 ABI-007 Every 2 Weeks	0
130 mg/m^2 ABI-007 Weekly	0

Grade 4

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	0
260 mg/m^2 ABI-007 Every 2 Weeks	0
130 mg/m^2 ABI-007 Weekly	0

Participant Counts of the Most Severe Grade for Hemoglobin Levels as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3) Primary · up to 54 months

Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) hemoglobin levels were graded using NCI CTCAE version 3: Grade 0 = within normal limits; Grade 1 = \< lower limit of normal - 100g/L; Grade 2 = \<100 - 80g/L; Grade 3 = \<80 - 65g/L; Grade 4 = \<65g/L

Grade 0

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	41
260 mg/m^2 ABI-007 Every 2 Weeks	25
130 mg/m^2 ABI-007 Weekly	13

Grade 1

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	17
260 mg/m^2 ABI-007 Every 2 Weeks	18
130 mg/m^2 ABI-007 Weekly	33

Grade 2

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	6
260 mg/m^2 ABI-007 Every 2 Weeks	6
130 mg/m^2 ABI-007 Weekly	19

Grade 3

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	0
260 mg/m^2 ABI-007 Every 2 Weeks	0
130 mg/m^2 ABI-007 Weekly	4

Grade 4

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	0
260 mg/m^2 ABI-007 Every 2 Weeks	0
130 mg/m^2 ABI-007 Weekly	1

The Number of Participants With at Least One Dose Reduction for ABI-007 Primary · Up to 53 months

Participants with at least one dose reduction for ABI-007. ABI-007 (Abraxane) dose could be reduced according to protocol guidelines if the participant was experiencing toxicities. Participants were allowed two ABI-007 (Abraxane) dose reductions during the course of the trial. This outcome is considered to be both a safety and an efficacy outcome.

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	36
260 mg/m^2 ABI-007 Every 2 Weeks	32
130 mg/m^2 ABI-007 Weekly	53

The Number of Participants With at Least One Dose Delay for ABI-007 Primary · Up to 53 months

Participants with at least one dose delay for ABI-007. Treatment delays of no longer than 2 weeks allowed participants to recovery from acute toxicity. If treatment was delayed beyond 2 weeks, continuing treatment on protocol was at the physician's discretion, based upon the best interests of the participant. This outcome is considered to be both a safety and an efficacy outcome.

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	40
260 mg/m^2 ABI-007 Every 2 Weeks	27
130 mg/m^2 ABI-007 Weekly	68

The Number of Participants With a Dose Interruption of ABI-007 Primary · Up to 53 months

Number of participants who interrupted (omitted) a dose at some point in the treatment period. This outcome is considered to be both a safety and an efficacy outcome.

Group	Value	95% CI
260 mg/m^2 ABI-007 Every 3 Weeks	2
260 mg/m^2 ABI-007 Every 2 Weeks	0
130 mg/m^2 ABI-007 Weekly	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 54 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

260 mg/m^2 ABI-007 Every 3 Weeks

Serious: 22/75 (29%)

Deaths: —

260 mg/m^2 ABI-007 Every 2 Weeks

Serious: 16/54 (30%)

Deaths: —

130 mg/m^2 ABI-007 Weekly

Serious: 32/79 (41%)

Deaths: —

Serious adverse events (71 terms)

Reaction	System	260 mg/m^2 ABI-007 Every 3…	260 mg/m^2 ABI-007 Every 2…	130 mg/m^2 ABI-007 Weekly
Dehydration	Metabolism and nutrition disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—
Mucosal inflammation	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Diverticulitis	Infections and infestations	—	—	—
Neuropathy	Nervous system disorders	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—
Arrhythmia	Cardiac disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Supraventricular tachycardia	Cardiac disorders	—	—	—
Colitis	Gastrointestinal disorders	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—
Gastric ulcer	Gastrointestinal disorders	—	—	—
Ileus	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Oesophagitis	Gastrointestinal disorders	—	—	—
Asthenia	General disorders	—	—	—
Catheter site pain	General disorders	—	—	—
Chest pain	General disorders	—	—	—
Fatigue	General disorders	—	—	—

Other adverse events (99 terms — click to expand)

Reaction	System	260 mg/m^2 ABI-007 Every 3…	260 mg/m^2 ABI-007 Every 2…	130 mg/m^2 ABI-007 Weekly
Fatigue	General disorders	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—
Neuropathy	Nervous system disorders	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Dysgeusia	Nervous system disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—
Nail disorder	Skin and subcutaneous tissue disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Mucosal inflammation	General disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Neuropathy peripheral	Nervous system disorders	—	—	—
Lacrimation increased	Eye disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—
Vision blurred	Eye disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Asthenia	General disorders	—	—	—
Chills	General disorders	—	—	—
Oedema peripheral	General disorders	—	—	—

Most-reported serious reactions: Dehydration, Vomiting, Diarrhoea, Anaemia, Cardiac failure congestive, Mucosal inflammation, Pyrexia, Diverticulitis.

Data from ClinicalTrials.gov NCT00281528 adverse events section.

Sponsor's own description

This is a multi-center, open-label, randomized Phase II study in previously untreated patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly infusion. All patients will also receive concurrent bevacizumab.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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 NCT00281528 (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: 22 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/NCT00281528.

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

NCT00281528

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (71 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Breast Neoplasms

Other Celgene trials

Verify against primary sources