Clinical trial · Interventional
Anti-Hormone Therapy (With Anastrazole and Fulvestrant) Before Surgery to Treat Postmenopausal Women With Breast Cancer.
Combined Fulvestrant and Anastrozole as Neo-adjuvant Endocrine Therapy in Postmenopausal Women With Hormone Receptor Positive Invasive Breast Cancer
NCT00921115CI-TRIAL-00066538completedPhase 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)
This study is being done to test the safety and effectiveness of two drugs, Anastrozole and Fulvestrant, used as combined therapy in the neo-adjuvant setting for hormone receptor positive invasive 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 |
|---|---|---|---|
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrazole | Drug | — | UNRESOLVED |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arimidex + Faslodex
- description
- Patients will have an Oncotype Dx performed and if the RS is \<25, they will receive Anastrazole and Fulvestrant for 16 weeks. On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.
- interventionNames
- Drug: Fulvestrant
- Drug: Anastrazole
Primary outcomes (1)
- measure
- Pathologic Complete Response (PCR) Rate
- timeFrame
- 4 months
- description
- Pathologic complete response (PCR) rate with 4 months of neo-adjuvant combination endocrine therapy (Anastrazole and Fulvestrant).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria
* Female patient \> 18 years of age.
* Histologically proven invasive adenocarcinoma of the breast.
* Patients must be candidates for neoadjuvant treatment (Tumor size \> 2cm and/or clinical N1 or N2).
* ER positive (\> 10% of cells) and/or PgR positive (\> 10% of the cells) and HER-2 negative disease (IHC 0 or 1+ and/or FISH negative, IHC 2+ and FISH negative)
* Menopausal status
* Patients must be post-menopausal as defined by one of the following criteria:
* Prior bilateral oophorectomy
* 12 months since LMP with no prior hysterectomy
* Patients \> 55 years with prior hysterectomy
* Patients \< 55 years of age and with a prior hysterectomy without oophorectomy, estradiol and FSH levels must be consistent with the patient being postmenopausal.
* Premenopausal or perimenopausal women who do not meet the postmenopausal criteria above are also eligible, but are required to undergo ovarian suppression with an LHRH agonist. Ovarian suppression can be initiated any time prior to or on day 1 of protocol therapy and must continue throughout protocol therapy.
* Performance status of 2 or better per SWOG criteria
* No prior chemotherapy or endocrine therapy for the current cancer diagnosis.
* If female of childbearing potential, pregnancy test is negative prior to initiation of ovarian suppression.
* Patients must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules.
* Oncotype Dx Recurrence Score \</= 25.
Exclusion criteria
* Patients with metastatic disease.
* The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications.
* Premenopausal without ovarian suppression.
* Pregnancy or lactation.
* Patients with concomitant or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
* Patients with emotional limitations are excluded from study
* Platelets less than 100 x 109 /L
* Total bilirubin greater than 1.5 x ULRR
* ALT or AST greater than 2.5 x ULRR
* History of bleeding diathesis (i.e., disseminated intravascular coagulation \[DIC\], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy).
* History of hypersensitivity to active or inactive excipients of fulvestrant (i.e. castor oil or Mannitol).
* Oncotype Dx Recurrence Score of \>25.References
Publications (0)
Data not yet available
No reference posted for this study.