Anti-Hormone Therapy (With Anastrazole and Fulvestrant) Before Surgery to Treat Postmenopausal Women With Breast Cancer.

NCT00921115 | Completed Phase 2 Results DMC

• 2 other identifiers: 11595IRUSANAS0092
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Invasive Breast Cancer

Keywords

hormone receptor positive; invasive breast cancer; endocrine therapy; Anastrazole; Fulvestrant; breast tumors; postmenopausal

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (PCR) Rate

  Pathologic complete response (PCR) rate with 4 months of neo-adjuvant combination endocrine therapy (Anastrazole and Fulvestrant).

  4 months

Study Arms (1)

Arimidex + Faslodex

EXPERIMENTAL

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.

Drug: Fulvestrant; Drug: Anastrazole

Interventions

Fulvestrant DRUG

Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.

Also known as: Faslodex

Arimidex + Faslodex

Anastrazole DRUG

Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles

Also known as: Arimidex

Arimidex + Faslodex

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Qamar Khan, MD
• Organization: University of Kansas Cancer Center

QKHAN@kumc.edu

(913) 588-6029

Study Officials

• Qamar Khan, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 16, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: March 20, 2023
• Last Updated: May 19, 2023
• Results First Posted: May 18, 2017

Record last verified: 2023-05

Locations

US (1)