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COMPLETEDPHASE2

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

An Open-label, Randomized, Comparative Pilot 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

NCT00394251•Celgene

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

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, histologically confirmed adenocarcinoma of the breast
•4. Must have met 1 of the following criteria:
•* T1-3, N1-3, M0, regardless of ER or PR status.
•* T \> 2 cm, N0, M0 (T2-3N0M0), regardless of ER or PR status.
•* T \> 1 cm, N0, M0 (T1cN0M0) and both ER and PR negative
•* T \> 1 cm, N0, M0, ER or PR positive and grade 3
•5. Patients with one sentinel lymph node metastasis 0.2-2 mm in size were not required to undergo completion axillary dissection unless only 1 sentinel lymph node was examined. This completion axillary dissection was optional if 1 out of 2 or more sentinel lymph nodes was positive for a micrometastasis. Therefore if 1 of 1 sentinel lymph node was positive for micrometastasis(0.2-2 mm), then a completion axillary dissection was required.

Exclusion Criteria

•T1b,c,N0M0 and ER or PR positive and grade 1 or 2 Tx tumors (regardless of nodal status) T4 disease \[i.e., patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes
•* Note: Sentinel lymph node micrometastasis \< 0.2 mm in considered N0 disease
•7. Negative surgical margins on lumpectomy or mastectomy specimen (no ink on invasive cancer and no ink on ductal carcinoma in situ \[DCIS\]).
•8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
•9. Normal electrocardiogram (ECG, as assessed by the investigator).
•10. No pre-existing peripheral neuropathy.
•11. It had not been longer than 84 days since the date of definitive surgery (eg, mastectomy or in the case of a breast-sparing procedure, axillary dissection).
•12. Laboratory values were to be as follows:
•* White blood cell count: \> or equal to 3,000/mm\^3
•* Absolute neutrophil count:\> or equal to 1,500/mm\^3
+39 more criteria

Locations (27)

Birmingham, Alabama, United States

Sedona, Arizona, United States

Denver, Colorado, United States

Torrington, Connecticut, United States

Indianapolis, Indiana, United States

Minneapolis, Minnesota, United States

Columbia, Missouri, United States

St Louis, Missouri, United States

Henderson, Nevada, United States

Raleigh, North Carolina, United States

Key Dates

Start Date

August 1, 2006

Primary Completion Date

March 1, 2007

Completion Date

February 1, 2008

Last Updated

November 25, 2019

Enrollment

197

ACTUAL participants

Conditions

Breast Cancer

Interventions

Adriamycin and Cytoxan (AC)

DRUG

ABI-007

DRUG

Taxol

DRUG

Bevacizumab

DRUG

pegfilgrastim

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer