Phase 2
N=79
Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00290745 ↗Enrolled (actual)
79
Serious AEs
—
Results posted
Dec 2020
Primary outcome: Primary: Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography — -5.0 change in tumor volume (mm) — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- letrozole (Drug); tamoxifen citrate (Drug); conventional surgery (Procedure); neoadjuvant therapy (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography |
-5.0 | 0.07 |
| PRIMARY Median Change in 6-month Tumor Volume Compared to Baseline Using Magnetic Resonance Imaging (MRI) |
-0.8 | <0.001 sig |
| SECONDARY Number of Responders to Neoadjuvant Therapy at Month 3 |
13; 10; 27; 17 | — |
| SECONDARY Number of Responders to Neoadjuvant Therapy at Month 6 |
22; 7; 26; 12 | — |
| SECONDARY Median Reduction in Tumor Volume by Estrogen Receptor Hormone (ER H-) Quartile Group |
-58.8; -70.3; -80.3; -71.1 | 0.538 |
| SECONDARY Median Reduction in Tumor Volume by PgR H-score by Quartile Group |
-69.1; -45.8; -69.6; -96.2 | 0.02 sig |
| SECONDARY Median Reduction in Tumor Volume by Ki-67 Average Score |
-73.0; -70.3 | 0.714 |
| SECONDARY Correlation Between Pathologic Tumor Size at Radiographic (MRI) Tumor Size |
0.46 | 0.001 sig |
| SECONDARY Correlation Between Pathologic Tumor Size and Mammographic Tumor Size |
0.02 | 0.906 |
Summary
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.
Eligibility Criteria
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 Characteristics
Data sourced from ClinicalTrials.gov (NCT00290745). 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.