Clinical trial · Interventional
Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ
Primary Hormonal Therapy for Ductal Carcinoma in Situ: Exploration of a Novel Approach to the Clinical Management of Noninvasive Breast Cancer
NCT00290745CI-TRIAL-00048642completedPhase 1 / Phase 2Results postedClinicalTrials.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: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. PURPOSE: This clinical trial is studying how well tamoxifen or letrozole work in treating women with ductal carcinoma in situ.
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)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- tamoxifen or letrozole
- description
- tamoxifen or letrozole work in treating women with ductal carcinoma in situ
- interventionNames
- Drug: letrozole
- Drug: tamoxifen citrate
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
Primary outcomes (2)
- measure
- Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography
- timeFrame
- Baseline and 6 months
- description
- Change in size of Ductal Carcinoma in situ (DCIS) for participants on hormonal therapy, as determined by mammography are determined by (1) largest diameter of tumor, as visualized on mammography (2) extent of disease on mammography (3) quantification of mammographically-detected change from baseline to 6-month and used to generate the change in tumor volume of mammographic extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of ductal carcinoma in situ (DCIS) on core biopsy
* No evidence of contralateral breast disease or palpable masses on breast examination
* No presence or suspicion of invasive cancer, including contralateral invasive cancer, on core biopsy and MRI
* No documented ipsilateral axillary adenopathy
* Planning to undergo lumpectomy or mastectomy
* Estrogen receptor (ER)-positive tumor by immunohistochemistry
PATIENT CHARACTERISTICS:
* Female patient
* Premenopausal or postmenopausal
* Postmenopausal is defined by any of the following:
* No spontaneous menses for \>= 1 year
* Bilateral oophorectomy
* Radiation castration and amenorrheic for \>= 3 months
* Follicle-stimulating hormone (FSH) \> 20 IU/L AND off all hormonal therapy (e.g., hormone replacement therapy or birth control pills) for \>= 1 month
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No co-morbidities contraindicating the use of tamoxifen, including any of the following:
* Prior history of thrombotic events
* History of hypercoagulable state
* History of endometrial hyperplasia
* Abnormal vaginal bleeding
* No history of contrast dye-related allergies/reactions
* No history of metal-containing prostheses or implants
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (2)
- BACKGROUNDChen YY, DeVries S, Anderson J, Lessing J, Swain R, Chin K, Shim V, Esserman LJ, Waldman FM, Hwang ES. Pathologic and biologic response to preoperative endocrine therapy in patients with ER-positive ductal carcinoma in situ. BMC Cancer. 2009 Aug 18;9:285. doi: 10.1186/1471-2407-9-285. PMID 19689789
- BACKGROUNDSwain RS, Chen YY, Wa C, et al.: Pathologic and biologic response to neoadjuvant anti-estrogen (AE) therapy in patients with ductal carcinoma in situ (DCIS). [Abstract] United States and Canadian Academy of Pathology 95th Annual Meeting, February 11-17, 2006, Atlanta, GA. A-186, 2006.