Phase 2
N=50
Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery
Estrogen Receptor-negative Breast Cancer · Estrogen Receptor-positive Breast Cancer · HER2-positive Breast Cancer · Progesterone Receptor-negative Breast Cancer · Progesterone Receptor-positive Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00194779 ↗Enrolled (actual)
50
Serious AEs
16.0%
Results posted
Mar 2018
Primary outcome: Primary: Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR) — 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- doxorubicin hydrochloride (Drug); cyclophosphamide (Drug); paclitaxel (Drug); filgrastim (Biological); capecitabine (Drug); methotrexate (Drug); vinorelbine tartrate (Drug); needle biopsy (Procedure); therapeutic conventional surgery (Procedure); immunohistochemistry staining method (Other); trastuzumab (Biological); tamoxifen citrate (Drug); letrozole (Drug); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR) |
29 | — |
| SECONDARY Number and Percent of Patients Reporting Grade 2, 3, 4, or Fatal Toxicities of These Regimens, Need for Dose Reduction, or Treatment Interruption or Discontinuation |
32 | — |
| SECONDARY Correlation of Molecular Markers With Response |
— | — |
| SECONDARY Relapse Rate in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed by Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy |
7 | — |
| SECONDARY Time to Progression |
NA | — |
| SECONDARY OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN |
1; .94; .90 | — |
| SECONDARY Disease-free Survival |
.97; .90; .84 | — |
| SECONDARY Clinical Response to Neoadjuvant Therapy |
6; 33; 6; 2 | — |
| SECONDARY Clinical Response to Paclitaxel |
23; 14; 4; 3; 1 | — |
Summary
This phase II trial studies how well giving combination chemotherapy and filgrastim together before surgery works in treating patients with human epidermal growth receptor 2 (HER2)-positive breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. 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. Giving doxorubicin hydrochloride, cyclophosphamide, and filgrastim together followed by paclitaxel before surgery may be an effective treatment for breast cancer
Eligibility Criteria
Inclusion Criteria
- Have known tumor HER-2/neu expression; if determination is "intermediate" by immunohistochemistry, fluorescent in situ hybridization (FISH) must be performed; protocol therapy is determined by HER-2/neu result
- Have histologically confirmed, operable breast cancer that is either:
- Hormone receptor (estrogen receptor [ER] or progesterone receptor [PR]) positive and HER2/neu positive or
- ER/PR negative
- Have radiographically measurable breast cancer > 1cm (Operable lesions are T1c-T3 and N0-N2a; histologic confirmation should be by core needle biopsy only)
- Be chemotherapy naïve
- Eastern Cooperative Oncology Group (ECOG) performance status of = = 1,500
- Platelet count >= 100,000
- Serum creatinine = = 60 years of age or who have a history of hypertension must have an echocardiogram or multi gated acquisition scan (MUGA) prior to enrollment; patients with breast cancer that is HER-2/neu positive who will receive herceptin (trastuzumab) must have an echocardiogram or MUGA scan; the left ventricular ejection fraction (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
- Women of childbearing potential must have a negative pregnancy test within seven days prior to registration
- Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures
Exclusion Criteria
- Primary tumor = 200 mm/hg)
- Current use of digitalis or beta blockers for congestive heart failure (CHF)
- Clinically significant pericardial effusion
- History of cardiac disease:
- 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
- Major surgery within 4 weeks of the start of study treatment without complete recovery
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- Known, existing uncontrolled coagulopathy
- Unwillingness to give written informed consent
- Unwillingness to participate or inability to comply with the protocol for the duration of the study
Data sourced from ClinicalTrials.gov (NCT00194779). 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.