Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Neoplasm Metastasis

Breast Diseases

Skin Diseases

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

260 mg/m\^2 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks

260 mg/m\^2 ABI-007 every 2 weeks and 10 mg/kg bevacizumab every 2 weeks

130 mg/m\^2 ABI-007 weekly (without a week of 'rest') and 10 mg/kg bevacizumab every 2 weeks

ABI-007 (Abraxane)

bevacizumab

Andrew Seidman, MD

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.

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

A Phase II Study of Weekly Versus Every 2-week Versus Every 3-week Administration of ABI-007 (Abraxane) in Combination With Bevacizumab in Women With Metastatic Breast Cancer.

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.

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

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

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

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

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.

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.

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.

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.

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.

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

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.

PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.

Celgene

260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.

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

260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks

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

130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks

130 mg/m^2 ABI-007 Weekly

Total

Age, Categorical

Age, Customized

Sex: Female, Male

Asian

Black, of African Heritage

White, Non-Hispanic and Non-Latino

White, Hispanic or Latino

Other (not specified)

Race/Ethnicity, Customized

Weight

Pre-menopausal

Post-menopausal

Menopausal status

0 - Asymptomatic

1. - Symptomatic but completely ambulatory
2. - Symptomatic, \<50% in bed during the day
3. - Symptomatic, \>50% in bed, but not bedbound
4. - Bedbound
5. - Death

Eastern Cooperative Oncology Group (ECOG) Performance Status

Time from Primary Diagnosis to Study Entry

Stage IV characteristics are the cancer can be any size (any T) and may or may not have spread to nearby lymph nodes (any N). It has spread to distant organs or to lymph nodes far from the breast (M1). The most common sites of spread are the bone, liver, brain, or lung,

Participants with Current Diagnosis at Stage IV

Associate Director, Clinical Trials Disclosure

The Percentage of Participants Confirmed Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)

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)

Grade 0

Grade 1

Grade 2

Grade 3

Grade 4

Treated population who had at least one post baseline value

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)

Kaplan Meier Estimate for Time to Disease Progression (TTP)

Treated population who achieved a complete or partial response

Kaplan Meier Estimate for Duration of Response

Kaplan Meier Estimate for Participant Survival

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)

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)

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)

The Number of Participants With at Least One Dose Reduction for ABI-007

The Number of Participants With at Least One Dose Delay for ABI-007

The Number of Participants With a Dose Interruption of ABI-007

Kaplan Meier Estimate for Progression-Free Survival (PFS)

Overall Study

Exemestane

Estrogens

Taxane

Aromatase Inhibitors

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15

exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks

IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks

Thomas BACHELOT, Md

In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab.

Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.

1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer

Phase III Randomized Multicenter Trial Comparing Continued Maintenance Therapy With the Bevacizumab + Taxane Versus Bevacizumab + Substituting Exemestane in Patients With Metastatic Breast Cancer or Locally Advanced With Estrogen Receptor Positive and Having at Least a Stable Disease After 16 to 18 Weeks of Treatment With Bevacizumab + Taxane.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer	NCT00281528	Breast Neoplasm... Neoplasm Metast...	ABI-007 (Abraxa... bevacizumab	18 Years -	Celgene
Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer	NCT00281528	Breast Neoplasm... Neoplasm Metast...	ABI-007 (Abraxa... bevacizumab	18 Years -	Celgene
1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer	NCT01303679	First Line Meta...	Paclitaxel Bevacizumab Exemestane	18 Years -	ARCAGY/ GINECO GROUP

Spots Global Cancer Trial Database for first line metastatic breast cancer