Arimidex With or Without Faslodex In Postmenopausal Women With HR Positive Breast Cancer

NCT00570323 | Completed Phase 2 Results DMC

• 2 other identifiers: H 20431IRUSFULV0060
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Over the last 3 decades, a steady shift has occurred in the management of breast cancer. Because it was traditionally viewed as a local disease, many advocated the use of radical surgery to achieve maximum survival benefit. This view has been slowly replaced by a broader biologic view that recognizes the often systemic nature of breast cancer, even when it appears to be localized to the breast. Results from randomized clinical trials have demonstrated that less extensive surgery, or lumpectomy plus radiation therapy, are optimal for local management of early breast cancer. In addition to the less radical approach to surgical treatment of breast cancer, other randomized clinical trials have established the value of postoperative systemic therapy in improving overall survival by eradicating micrometastatic disease, the major cause of mortality from breast cancer. Despite the well-documented benefits of adjuvant systemic therapy, it is not effective in preventing death from breast cancer in all patients who are candidates for such treatment. The worth of such therapy can only be judged in retrospect upon disease relapse, a time when breast cancer is nearly always incurable. Currently, there are few reliable methods to predict the success or failure of a particular postoperative treatment modality, and better ways to predict and optimize outcome are needed. Combination endocrine therapy: Using endocrine agents with different mechanisms of action together has the potential advantage of more effectively blocking ER signaling, thus improving the efficacy of such agents against breast cancer. In the past, attempts to combine endocrine agents for ER-positive breast cancer have had mixed results, depending on the setting and the patient population studied. Endocrine agents without any agonist effect could potentially be used in combination with aromatase inhibitors, under the rationale that the combination would maximally blockade estrogen receptor signaling, thus potentially improving the antitumor effect. Fulvestrant (FASLODEX) is a pure estrogen antagonist with no known agonist effect; thus, it has the potential to provide additional benefit when combined with an aromatase inhibitor. This concept provides the rationale for using the combination of anastrazole and fulvestrant in this study.

Conditions

Breast Cancer

Keywords

Breast Cancer; HORMONE RECEPTOR POSITIVE BREAST CANCER

Outcome Measures

Primary Outcomes (1)

• Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples

  The primary endpoint is change in Ki-67 levels from baseline (pre) to day 28 (post) biopsy samples. Ki-67 levels were log-transformed to achieve approximately normally distributed data. The differences in these log-transformed values between post vs. pre biopsy samples were calculated. This difference represents the log of the ratio of post vs. pre Ki-67 levels in the original scale.

  baseline (pre) to day 28 (post)

Secondary Outcomes (2)

• Clinical Response

  1 Year

• Pathologic Complete Response

  1 Year

Study Arms (2)

ARM A / Arimidex with Faslodex

ACTIVE COMPARATOR

Arimidex with Faslodex in postmenopausal women

Drug: Arimidex; Drug: Faslodex

ARM B Arimidex without Faslodex

ACTIVE COMPARATOR

Arimidex without Faslodex in postmenopausal women.

Drug: Arimidex

Interventions

Arimidex DRUG

Aromatase inhibitors

Also known as: Anastrozole

ARM A / Arimidex with Faslodex; ARM B Arimidex without Faslodex

Faslodex DRUG

Hormone Receptor

Also known as: Fulvestrant

ARM A / Arimidex with Faslodex

Eligibility Criteria

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

You may qualify if:

• All subjects must be female.
• Postmenopausal status, defined as any one of the following criteria:
• Documented history of bilateral oophorectomy.
• Age 60 years or more.
• Age 45 to 59 and satisfying one or more of the following criteria:
• Amenorrhea for at least 12 months and intact uterus.
• Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) and estradiol concentration within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement.
• Patients must have histologically confirmed invasive breast cancer with a primary tumor of 3 cm or more in greatest dimension as measured by clinical examination.
• Estrogen receptor and/or progesterone receptor positive disease.
• Patients must not have received any prior treatment for current or newly diagnosed breast cancer.
• Patients must have not received previous treatment with any of the study medications or similar drugs.
• No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years.
• WHO performance status of 0, 1, or 2.
• Adequate organ function defined as follows:
• Adequate renal function, defined by a serum creatinine within 3 times the upper limits of normal.

You may not qualify if:

• Premenopausal status.
• Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ.
• Patients with brain metastasis.
• WHO performance status of 3 or 4.
• Is judged by the investigator, uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial. - Concurrent treatment with estrogens or progestins. Patients must stop these drugs at least two weeks prior to study entry.
• Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
• Platelet count less than 75,000.
• In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections.
• History of hypersensitivity to castor oil.
• Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded) - Patients with recurrent breast cancer.
• Patients with contralateral second primary breast cancers are eligible.

Sponsors & Collaborators

• Mothaffar Rimawi: lead
• AstraZeneca: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; Fulvestrant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Tao Wang
• Organization: Baylor College of Medicine

taow@bcm.edu

7137985388

Study Officials

• Mothaffar Rimawi, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 10, 2007
• Study Start: December 1, 2007
• Primary Completion: October 1, 2016
• Study Completion: December 5, 2018
• Last Updated: July 28, 2020
• Results First Posted: March 4, 2019

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)