Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive HER2-Negative Node-Negative Breast Cancer Patients to Assess Responses and Mechanisms of Endocrine Resistance
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|ClinicalTrials.gov Identifier: NCT03219476|
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Invasive Breast Cancer||Drug: Anastrozole Drug: Letrozole Drug: Exemestane Drug: Tamoxifen||Phase 2|
STUDY RATIONALE: Patients with HR+ HER2- node-negative breast cancers generally undergo surgical resection upfront, followed by adjuvant chemotherapy, if needed, in addition to adjuvant endocrine therapy. Because endocrine therapy is primarily delivered in the postoperative setting, the ability to assess the tumor response to this treatment modality is lost and very difficult to assess. This study offers the unique opportunity to assess the responsiveness of breast tumors to endocrine therapy while the tumors are still in vivo by treating patients with endocrine therapy before surgery and assessing molecular changes with treatment. By comparing pre- and post-treatment levels of molecular markers in individual tumors, the team expects to identify predictors of responsiveness to existing agents and identify new candidate therapeutic targets.
PRIMARY OBJECTIVE: The primary objective is to determine the frequency of increased HER family of receptor tyrosine kinases protein expression in tumors, following treatment with neoadjuvant endocrine therapy and their correlation with Ki-67 tumor responses. The team will measure cancer cell protein levels of growth factor receptors of the HER family before and after neoadjuvant endocrine therapy. The data will be used to inform a future randomized trial of combined endocrine and the most promising anti-HER targeted therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive HER2-Negative Node-Negative Breast Cancer Patients to Assess Responses and Mechanisms of Endocrine Resistance|
|Actual Study Start Date :||February 5, 2017|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 1, 2021|
Experimental: Neoadjuvant endocrine therapy treatment (physician's choice)
Once enrolled, patients would be treated with the current standard-of-care endocrine therapy. Choice of endocrine therapy (aromatase inhibitors or tamoxifen) would be decided by medical oncologist, following a review of the patient's medical history and menstrual status. The patient would be treated with endocrine therapy in a neoadjuvant setting for four weeks, with dosing continuing until surgery.
1 mg once daily.
2.5mg once daily.
25 mg once daily.
20 mg once daily.
- Protein expression will be quantified on slides, using optimized immunohistochemical protocols for planned study biomarkers. [ Time Frame: At four weeks. ]
- Ki-67 assessment specimens will be assessed by manual counting of stained tumor cells. [ Time Frame: At four weeks. ]
- Ki-67 assessment specimens will be assessed by quantitative immunohistochemistry. [ Time Frame: At four weeks. ]
- Changes in tumor size will be assessed with unilateral mammogram. [ Time Frame: At four weeks. ]
- Patient outcomes (e.g., distant recurrences) will be assessed by chart review in follow-up. [ Time Frame: Five years. ]
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): NCT03219476
|Contact: Medical College of Wisconsin Clinical Trials Officeemail@example.com|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Lubna Chaudhary, MD 414-805-4600 firstname.lastname@example.org|
|Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office 414-805-8900 email@example.com|
|Principal Investigator:||Lubna Chaudhary||Medical College of Wisconsin|