Arimidex With or Without Faslodex In Postmenopausal Women With HR Positive Breast Cancer (PACT001)
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|ClinicalTrials.gov Identifier: NCT00570323|
Recruitment Status : Completed
First Posted : December 10, 2007
Results First Posted : March 4, 2019
Last Update Posted : July 28, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Arimidex Drug: Faslodex||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Neoadjuvant Arimidex With or Without Faslodex in Postmenopausal Women With Hormone Receptor Positive Breast Cancer|
|Actual Study Start Date :||December 2007|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||December 5, 2018|
Active Comparator: ARM A / Arimidex with Faslodex
Arimidex with Faslodex in postmenopausal women
Other Name: Anastrozole
Other Name: Fulvestrant
Active Comparator: ARM B Arimidex without Faslodex
Arimidex without Faslodex in postmenopausal women.
Other Name: Anastrozole
- Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples [ Time Frame: baseline (pre) to day 28 (post) ]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.
- Clinical Response [ Time Frame: 1 Year ]Measurable lesions were examined at baseline to treatment completion.Clinical Response was defined by Solid Tumor Response Criteria (RECIST).
- Pathologic Complete Response [ Time Frame: 1 Year ]Pathologic response was defined as no residual invasive tumor on histopathological analysis in the breast primary. Patients were assessed according to the Chevallier classification of pathologic response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570323
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mothaffar Rimawi, MD||Baylor College of Medicine|