Clinical trial · Interventional
Neoadjuvant Chemotherapy Using Doxorubicin and Paclitaxel in Treating Women With Large Breast Cancer
Neoadjuvant Chemotherapy in Palpable Breast Cancer: Evaluation of Physiologic, Radiologic, and Molecular Markers in Predicting Response
NCT00096291CI-TRIAL-00026896completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery. PURPOSE: This randomized phase II trial is comparing two different regimens of doxorubicin and paclitaxel to see how well they work 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin followed by Paclitaxel | Other | — | UNRESOLVED |
| Paclitaxel followed by Doxorubicin | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sequence Doxorubicin followed by Paclitaxel
- description
- Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy: Doxorubicin followed by Paclitaxel versus Paclitaxel followed by Doxorubicin
- interventionNames
- Other: Doxorubicin followed by Paclitaxel
- Other: Paclitaxel followed by Doxorubicin
- type
- OTHER
- label
- Sequence of neoadjuvant CT: Paclitaxel followed by Doxorubicin
- description
- Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy: Doxorubicin followed by Paclitaxel versus Paclitaxel followed by Doxorubicin
- interventionNames
- Other: Paclitaxel followed by Doxorubicin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of invasive breast cancer
* Tumor ≥ 3 cm and palpable
* Multiple masses are allowed provided at least 1 mass is ≥ 3 cm
* Clinically positive axillary or supraclavicular lymph nodes allowed
* Fine needle aspiration or core needle biopsy positive for invasive breast cancer AND/OR fine needle aspiration of lymph nodes positive
* HER2/neu-positive OR negative
* No inflammatory breast cancer
* No distant metastases
* Hormone receptor status:
* Estrogen receptor (ER)-positive OR ER-negative
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Premenopausal or postmenopausal
Performance status
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* SGOT ≤ 2 times ULN
Renal
* Not specified
Cardiovascular
* LVEF ≥ 50%
* No congestive heart failure
* No serious conduction system abnormality
* No other significant cardiovascular disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Patients with other prior or concurrent malignancies allowed provided they have received no prior chemotherapy AND they are likely to have been cured from a prior malignancy
* No severe medical or psychiatric condition that would preclude study compliance
* No known HIV positivity
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* No prior hormonal therapy for breast cancer
Radiotherapy
* No prior radiotherapy for this malignancy
Surgery
* Not specifiedReferences
Publications (2)
- RESULTTaghian AG, Abi-Raad R, Assaad SI, Casty A, Ancukiewicz M, Yeh E, Molokhia P, Attia K, Sullivan T, Kuter I, Boucher Y, Powell SN. Paclitaxel decreases the interstitial fluid pressure and improves oxygenation in breast cancers in patients treated with neoadjuvant chemotherapy: clinical implications. J Clin Oncol. 2005 Mar 20;23(9):1951-61. doi: 10.1200/JCO.2005.08.119. PMID 15774788
- RESULTYeh E, Slanetz P, Kopans DB, Rafferty E, Georgian-Smith D, Moy L, Halpern E, Moore R, Kuter I, Taghian A. Prospective comparison of mammography, sonography, and MRI in patients undergoing neoadjuvant chemotherapy for palpable breast cancer. AJR Am J Roentgenol. 2005 Mar;184(3):868-77. doi: 10.2214/ajr.184.3.01840868. PMID 15728611