Clinical trial · Interventional
Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy
A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy With Radiation Therapy
- 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 stimulate the growth of breast cancer cells. Tamoxifen may fight breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by decreasing estrogen production. It is not yet known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer. PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anastrozole | Drug | Anastrozole | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- description
- tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years
- interventionNames
- Drug: tamoxifen citrate
- Radiation: Radiation Therapy
- type
- EXPERIMENTAL
- label
- Group 2
- description
- anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years
- interventionNames
- Drug: anastrozole
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Percentage of Patients Free From Breast Cancer
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed ductal carcinoma in situ (DCIS) of the breast
* Mixed DCIS and lobular carcinoma in situ (LCIS) allowed
* Must have undergone lumpectomy
* Margins must be histologically free of disease
* Re-excision to obtain tumor-free margins allowed
* No more than 84 days since prior lumpectomy or re-excision
* More than 1 area of DCIS allowed provided all disease is removed with tumor-free margins
* Masses or clusters of calcification that are clinically or mammographically suspicious must be biopsied
* No prior invasive breast cancer or DCIS
* Patients with a history of LCIS are eligible
* No prior or concurrent invasive (including microinvasive) breast cancer
* DCIS "suspicious" for microinvasion allowed
* No bilateral malignancy
* No mass or mammographic abnormality suspicious for malignancy in the opposite breast unless not malignant as proven by biopsy
* No Paget's disease of the nipple
* No positive ipsilateral axillary or intramammary nodes
* No palpable nodes in the ipsilateral or contralateral axilla or palpable supraclavicular or infraclavicular nodes unless not involved with tumor as proven by biopsy
* Hormone receptor status:
* Estrogen- or progesterone-receptor positive as determined by immunohistochemistry
* Borderline results are considered positive
PATIENT CHARACTERISTICS:
Age
* See Menopausal status
Sex:
* Female
Menopausal status:
* Postmenopausal as defined by at least 1 of the following:
* Prior documented bilateral oophorectomy
* At least 12 months without spontaneous bleeding
* Age 55 or over with prior hysterectomy without oophorectomy
* Age 54 or under with prior hysterectomy without oophorectomy with a documented follicle-stimulating hormone level in the postmenopausal range
Performance status
* Zubrod 0-2
Life expectancy
* At least 10 years (excluding diagnosis of breast cancer)
Hematopoietic
* WBC normal
Hepatic
* AST normal
* Bilirubin normal
* Alkaline phosphatase normal
* No hepatic disease that would preclude administration of study drugs
Renal
* Creatinine normal
* No renal disease that would preclude administration of study drugs
Cardiovascular
* No prior documented cerebral vascular accident or transient ischemic attack
* No prior deep vein thrombosis
* No cardiovascular disease that would preclude administration of study drugs
* No uncontrolled hypertension (i.e., systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 110 mm Hg based on the average of 2 or more readings at each of 2 or more visits after initial screening)
* No uncontrolled atrial fibrillation
Pulmonary
* No pulmonary embolus
Other
* Not pregnant or nursing
* Patients with a history of non-breast malignancies are eligible provided they have been disease-free for ≥ 5 years and are deemed by their physician to be at low risk for recurrence
* No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the colon, or melanoma in situ
* No psychiatric or addictive disorders that would preclude informed consent
* No uncontrolled diabetes, defined as hemoglobin A1C greater than 9% (fasting glucose 200 mg/dL)
* No nonmalignant systemic disease that would preclude administration of study drugs
PRIOR CONCURRENT THERAPY:
Endocrine therapy
* No prior or concurrent aromatase inhibitors (e.g., exemestane or letrozole) or tamoxifen
* No concurrent raloxifene or other selective estrogen receptor modulators
* No concurrent sex hormone therapy (e.g., estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone releasing hormone analogs, prolactin inhibitors, or antiandrogens)
* Low-dose estrogen vaginal creams or Estring allowed
Radiotherapy
* Radiotherapy for this cancer initiated before study is allowed
Surgery
* See Disease Characteristics
* No prior or concurrent mastectomy for DCIS
* Prior sentinel node biopsy or axillary node dissection allowed provided nodes are pathologically negative
Other
* No concurrent warfarin
* No other systemic therapy for this cancer initiated before study
* No other concurrent anticancer therapy unless permitted by the protocol investigator
* No concurrent participation in another clinical trial of therapy for DCIS
* Concurrent participation in protocol NSABP-B-39 allowedReferences
Publications (5)
- BACKGROUNDLand SR, Ritter MW, Costantino JP, Julian TB, Cronin WM, Haile SR, Wolmark N, Ganz PA. Compliance with patient-reported outcomes in multicenter clinical trials: methodologic and practical approaches. J Clin Oncol. 2007 Nov 10;25(32):5113-20. doi: 10.1200/JCO.2007.12.1749. PMID 17991930
- BACKGROUNDMargolese RG, Cecchini RS, Julian TB, Ganz PA, Costantino JP, Vallow LA, Albain KS, Whitworth PW, Cianfrocca ME, Brufsky AM, Gross HM, Soori GS, Hopkins JO, Fehrenbacher L, Sturtz K, Wozniak TF, Seay TE, Mamounas EP, Wolmark N. Anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial. Lancet. 2016 Feb 27;387(10021):849-56. doi: 10.1016/S0140-6736(15)01168-X. Epub 2015 Dec 11. PMID 26686957
- BACKGROUNDGanz PA, Cecchini RS, Julian TB, Margolese RG, Costantino JP, Vallow LA, Albain KS, Whitworth PW, Cianfrocca ME, Brufsky AM, Gross HM, Soori GS, Hopkins JO, Fehrenbacher L, Sturtz K, Wozniak TF, Seay TE, Mamounas EP, Wolmark N. Patient-reported outcomes with anastrozole versus tamoxifen for postmenopausal patients with ductal carcinoma in situ treated with lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial. Lancet. 2016 Feb 27;387(10021):857-65. doi: 10.1016/S0140-6736(15)01169-1. Epub 2015 Dec 11. PMID 26686960
- DERIVEDWapnir IL, Cecchini RS, Dignam JJ, Anderson SJ, Li J, Suga JM, Brufsky AM, Hopkins JO, Zeitzer K, Lyons JA, Conlin AK, Kuerer HM, Siddique S, Vallow LA, Albain KS, Cianfrocca ME, Julian TB, Boileau JF, Mamounas EP, Wolmark N. Lumpectomy Margins and Local Recurrence in DCIS: Results From the NRG Oncology/NSABP B-35 Randomized Clinical Trial. JAMA Surg. 2026 Jul 1:e262340. doi: 10.1001/jamasurg.2026.2340. Online ahead of print. PMID 42384406
- DERIVEDDuggal S, Robin J, Julian TB. Ductal carcinoma in situ: an overview. Expert Rev Anticancer Ther. 2013 Aug;13(8):955-62. doi: 10.1586/14737140.2013.820557. PMID 23984897