Phase 2
Completed N=197
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
Source: ClinicalTrials.gov NCT00394251 ↗Enrolled (actual)
197
Serious AEs
25.9%
Results posted
Jul 2013
Primary outcomePrimary: Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 3 Months Post Chemotherapy — 65; 74; 65; 77 participants — p=0.641
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 3 Months Post Chemotherapy |
65; 74; 65; 77; 36; 50 | 0.641 |
| PRIMARY Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 6 Months Post Chemotherapy |
49; 62; 46; 65; 25; 42 | 0.323 |
| SECONDARY The Cumulative Dose of Taxane Delivered During Study |
950.5; 660.8 | — |
| SECONDARY Mean Taxane Dose Intensity Per Week |
118.82; 82.60 | — |
| SECONDARY Percent of Protocol Taxane Dose |
91.40; 94.40 | — |
| SECONDARY Summary of Participant Treatment Exposure, Dose Interruptions, Dose Reductions, and Dose Delays |
95; 95; 95; 94; 82; 84 | — |
| SECONDARY Myelosuppression During Taxane Dosing Cycles |
58; 43; 11; 8; 6; 5 | — |
| SECONDARY Change From Baseline in Percent Left Ventricular Ejection Fraction (% LVEF) at the Final Evaluation |
-1.0; -1.0 | — |
| SECONDARY Summary of Participants' Most Severe Grade for Liver and Renal Function Laboratory Adverse Experiences During Study (All Treatment Cycles) |
69; 70; 26; 29; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
A patient was eligible for inclusion in this study only if all of the following criteria were met:
- Female, age greater than or equal to 18 to less than or equal to 70 years old.
- Estrogen receptor (ER) and progesterone receptor (PR) status have been determined.
- Operable, histologically confirmed adenocarcinoma of the breast
- 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
- 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.
- Patients with more than one sentinel node micrometastasis or 1 node with a micrometastasis > 2 mm and/or T3 disease must have undergone completion, standard axillary dissection. -Note: the following were not eligible-
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 or equal to 3,000/mm^3
- Absolute neutrophil count: > or equal to 1,500/mm^3
- Platelets:> or equal to 100,000/mm^3
- Hemoglobin: > or equal to 8g/dL
- Bilirubin: or equal to 1.0 or urine dipstick for proteinuria > or equal to 2+ (patients discovered to have > or equal to 2+ proteinuria on dipstick urinalysis at baseline should have undergone a 24 hour urine collection and must have demonstrated 150 mmHg and /or diastolic blood pressure> 100 mmHg on antihypertensive medications) or New York Heart Association (NYHA) Grade 2 or greater congestive heart failure.
- History or coagulopathy, bleeding diathesis, therapeutic anticoagulation other than low dose or chronic acetyl salicylic acid (ASA)> or equal to 325 mg. per day. Low dose coumadin for anticoagulation of venous access device or low dose molecular weight heparin (LMWH) for deep vein thrombosis prophylaxis or low dose (325 mg or less) ASA prophylaxis are allowed, but are best avoided if the treating physician feels it is safe to do so.
- Left Ventricular Ejection Fraction (LVEF) on cardiac echocardiography (ECHO) or equal to 74%. LVEF of greater than 75% at baseline should have been re- reviewed and/or the test repeated as it could be falsely elevated.
- Patients who were receiving concurrent immunotherapy.
- A history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of breast cancer recurrence or which could shorten a patient's survival.
- Patient had had an organ allograft.
- Patient was pregnant or breastfeeding.
- Patient was unable to comply with requirements of study.
- Patient was receiving any other investigational drugs.
Data sourced from ClinicalTrials.gov (NCT00394251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.