Phase 2
Completed N=60
Doxorubicin Hydrochloride, Cyclophosphamide, and Filgrastim Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation With or Without Trastuzumab in Treating Patients With Breast Cancer Previously Treated With Surgery
Estrogen Receptor-Positive Breast Cancer · HER2-positive breast cancer · Stage IA Breast Cancer · Stage IB Breast Cancer
Source: ClinicalTrials.gov NCT00407888 ↗
Enrolled (actual)
60
Serious AEs
8.3%
Results posted
Aug 2017
Primary outcomePrimary: Disease-free Survival Following a Dose-intensive Weekly Regimen of Adriamycin + Oral Cyclophosphamide Augmented With G-CSF Support Followed by Abraxane and Herceptin — 56 Participants
Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy and filgrastim together with trastuzumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride, cyclophosphamide, and filgrastim together followed by paclitaxel albumin-stabilized nanoparticle formulation and trastuzumab works in treating patients with breast cancer previously treated with surgery
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival Following a Dose-intensive Weekly Regimen of Adriamycin + Oral Cyclophosphamide Augmented With G-CSF Support Followed by Abraxane and Herceptin |
56 | — |
| SECONDARY Delivered Dose Intensity of the Regimen |
92.6; 92.1; 88.0 | — |
| SECONDARY Toxicity Associated With This Regimen |
37; 43; 5; 2; 3 | — |
| SECONDARY Time to Treatment Failure |
2.7 | — |
| SECONDARY Overall Survival |
59; 53 | — |
Eligibility Criteria
Inclusion Criteria
- Have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected; (this regimen is not intended for neoadjuvant treatment)
- 4 + nodes
- OR if 1-3 + nodes, either ER OR HER-2/neu+
- OR have high-risk node negative disease that is HER-2/neu positive OR >= 2.0 cm tumor size
- HER-2/new + definition: patient has known tumor HER-2/new expression = 3+ by IHC or, if 2+ by IHC confirmed to be FISH positive
- Patients with clinically apparent cardiac disease, or history of same, are not eligible; patients who are >= 60 years of age or who have a history of hypertension must have an echocardiogram or MUGA prior to enrollment; patients with breast cancer that is HER-2/neu positive and a treatment plan that includes Herceptin must have an echocardiogram or MUGA scan prior to enrollment; the LVEF must be within the institutional normal range; if LVEF is > 75%, the investigator should consider having the LVEF reviewed or repeating the MUGA prior to registration
- WBC >= 4,000
- ANC >= 1,500
- Platelet count >= 100,000
- Serum creatinine = 200 mm/hg)
- Current use of digitalis or beta blockers for CHF
- Clinically significant pericardial effusion
- Myocardial infarction documented as a clinical diagnosis or by EKG or any other test
- Documented congestive heart failure
- Documented cardiomyopathy
- Documented arrhythmia or cardiac valvular disease that requires medication or is medically significant
- Patients who have received prior chemotherapy or radiotherapy are not eligible
- Patients who are pregnant or breastfeeding are not eligible; women of child bearing potential must agree to practice adequate contraception
- Patients with active infection are not eligible
- Patients who are known to be infected with HIV, hepatitis B or hepatitis C are not eligible; testing is not required unless there is a high index of clinical suspicion
- Patients suffering from psychiatric impairment are not eligible
Data sourced from ClinicalTrials.gov (NCT00407888). 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.