Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Taxane

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Adriamycin 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).

Adriamycin 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).

Adriamycin (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).

Adriamycin and Cytoxan (AC)

260 mg/m\^2 IV on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)

ABI-007

175 mg/m\^2 intravenously (IV) on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)

Taxol

10 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).

6 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.

pegfilgrastim

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.

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

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).

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).

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

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

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

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.

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.

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

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

Celgene

AC --> ABI-007

AC --> Taxol

Total

Age, Continuous

>=65 years

< 65 years

Age, Customized

Sex: Female, Male

Asian

White, non-Hispanic, non-Latino

White, Hispanic or Latino

Black, of African heritage

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

Weight

premenopausal

postmenopausal

Menopausal Status

I: tumor <=2.0, lymph nodes clear, no metastasis

IIa: tumor <=2.0 cm, regional lymph node

IIb: tumor >2.0<5.0cm, regional lymph nodes

IIIa: tumor may be >5.0 cm, regional lymph nodes

IIIb: tumor extending to chest wall or skin

IIIc: tumor with extensive lymph node involvement

IV: distant metastasis

unknown

American Joint Committee on Cancer (AJCC) 6th edition staging for breast cancer was used to define stage at primary diagnosis. The scale ranges from stage I (primary tumor \<=2.0 cm, no regional or distant lymph node involvement) to stage IV (primary tumor of any size, with both regional and distant lymph node involvement). Each stage includes combinations of ratings for the primary tumor, regional lymph node involvement, and metastasis. Illustrative examples of stages appear in the data table. Each higher stage represents increasingly poor prognosis.

Stage at Primary Diagnosis

Positive

Negative

Defined as detectable presence (positive) or absence (negative) of estrogen receptors in tumor biopsy sample

Estrogen Receptor Status

Defined as detectable presence (positive) or absence (negative) of progesterone receptors in tumor biopsy sample

Progesterone Receptor Status

0 (Fully active)

1 (Restrictive but ambulatory)

Using Eastern Cooperative Oncology Group (ECOG) performance status scale (Oken, M.M., Creech, R.H., Tormey, D.C., Horton, J., Davis, T.E., McFadden, E.T., Carbone, P.P.: Toxicity And Response Criteria Of The Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655, 1982).

Eastern Cooperative Oncology Group (ECOG) Performance Status

0 (None)

Not reported

Physician's evaluation of peripheral neuropathy used the National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE Version 3.0) severity scale which is a five step scale with 1=mild adverse event and 5 = death related to an adverse event.

Physician's Assessment of Peripheral Neuropathy

Associate Director, Clinical Trials Disclosure

Participants in the treated population who received at least 1 dose of taxane.

The Cumulative Dose of Taxane Delivered During Study

Mean Taxane Dose Intensity Per Week

Comparison of percentage of participants with at least one taxane-emergent toxicity

At least 1 AE at 3 Months

Neurology: Neuropathy: Sensory

Constitutional Symptoms: Fatigue

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

Endocrine: Hot Flashes/Flushes

Cardiac General: Hypertension

Pain: Arthralgia

Hemorrhage/Bleeding: Nasal

Pain: Other - Extremity

Pain: Myalgia

Dermatology/Skin: Nail Changes

Constitutional Symptoms: Insomnia

260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.

ABI-007 Subset

Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).

175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.

Taxol Subset

Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).

Participants in the Treated Population for whom safety data was available 3 months post-chemotherapy

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

Percent of Protocol Taxane Dose

Completed 4 cycles of Adriamycin/Cytoxan (AC)

Received pegfilgrastim for 4 cycles during AC

Completed 4 cycles of taxane

Completed 18 cycles of bevacizumab

One or more dose reduction: Adriamycin

One or more dose reduction: Cytoxan

One or more dose reduction: Taxane

One or more dose interruption: Adriamycin

One or more dose interruption: Cytoxan

One or more dose interruption: Taxane

One or more dose interruption: Bevacizumab

One or more delay in study regimen

Discontinued pegfilgrastim during AC cycles

Administered pegfilgrastim during taxane cycles

Summary of Participant Treatment Exposure, Dose Interruptions, Dose Reductions, and Dose Delays

ANC (grades 1-4)

Taxane-related, grades 1-4

Taxane-related, grades 3-4

Participants in the treated population who received at least 1 dose of taxane and had laboratory values.

Myelosuppression During Taxane Dosing Cycles

Participants in the treated population who had both baseline and one treatment measurement for %LVEF

Change From Baseline in Percent Left Ventricular Ejection Fraction (% LVEF) at the Final Evaluation

Alkaline phosphatase, Grade 0

Alkaline phosphatase, Grade 1

Alkaline phosphatase, Grade 2

ALT, Grade 0

ALT, Grade 1

ALT, Grade 2

ALT, Grade 4

AST, grade 0

AST, grade 1

AST, grade 2

AST, grade 3

Bilirubin, grade 0

Bilirubin, grade 1

Bilirubin, grade 3

Creatinine, grade 0

Creatinine, grade 1

Treated population with at least one post-treatment laboratory measure.

Summary of Participants' Most Severe Grade for Liver and Renal Function Laboratory Adverse Experiences During Study (All Treatment Cycles)

At least 1 AE at 6 Months

Participants in the Treated Population for whom safety data was available 6 months post-chemotherapy

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

Overall Study

Spots Global Cancer Trial Database for 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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial