Clinical trial · Interventional
Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well neoadjuvant docetaxel works in treating women who are undergoing surgery for breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel
- description
- Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer.
- interventionNames
- Biological: pegfilgrastim
- Drug: docetaxel
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
Primary outcomes (1)
- measure
- Correlation between change in apoptosis and proliferation with response after definitive surgery
- timeFrame
- Definitive surgery
Secondary outcomes (1)
- measure
- Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed infiltrating carcinoma of the breast * Unresected clinical stage T1c, T2, T3, or T4 lesion, any N * Newly diagnosed disease * Diagnostic mammogram and an ultrasound of the affected breast within 3 months before study entry * Mammogram of the contralateral breast within 6 months before study entry * Clinically measurable disease * Hormone receptor status: * Immunohistochemical staining for estrogen and progesterone and HER2/neu receptors must be obtained on initial diagnostic material PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8 g/dL Hepatic * Bilirubin no greater than 1.5 times normal Renal * Creatinine no greater than 1.5 times normal Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No medical condition that would put the patient at unnecessary risk of potentially serious complications during study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for current breast cancer Endocrine therapy * At least 1 month since prior tamoxifen or raloxifene for breast cancer prevention * No prior endocrine therapy for current breast cancer Radiotherapy * No prior radiotherapy for current breast cancer Surgery * Not specified
References
Publications (0)
Data not yet available