Study on Tamoxifen Citrate or Z-Endoxifen Hydrochloride for Treating Advanced Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02311933
This clinical trial is comparing two hormone therapies, tamoxifen citrate and z-endoxifen hydrochloride, to see which is more effective in treating breast cancer that has spread and is estrogen receptor-positive but HER2-negative.
Patient Parameters
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Program Overview
The purpose of this study is to determine if tamoxifen citrate or z-endoxifen hydrochloride is more effective in treating breast cancer that has spread to nearby tissues or other parts of the body and is estrogen receptor-positive but HER2-negative. These hormone therapies work by reducing the amount of estrogen in the body, which can help slow the growth of cancer cells.
Description
This study is divided into two main parts: Phase I and Phase II.
In Phase I, researchers will assess the safety of combining atezolizumab, with or without tiragolumab, with chemotherapy drugs oxaliplatin and 5-FU before surgery. The goal is to see if this combination can completely eliminate cancer in about 20% of patients with localized esophageal or gastroesophageal junction (GEJ) adenocarcinoma.
In Phase II, the effectiveness of the treatment will be further evaluated by examining how much the tumors shrink in patients who receive the therapy.
The study will also monitor the overall safety and tolerability of the treatment after surgery, as well as track how long patients remain free of disease and their overall survival rates. Additionally, researchers will explore changes in the tumor environment before and after the treatment to understand how the combination of chemotherapy and immunotherapy affects the cancer.
Eligibility Criteria
Inclusion Criteria
- Women who agree to have a biopsy to confirm their breast cancer is estrogen receptor-positive and HER2-negative.
- Must have been treated with an aromatase inhibitor before and have either primary or secondary resistance to endocrine therapy.
- Must have measurable disease or bone-only disease.
- No history of tumors involving the spinal cord or heart.
- No current evidence of severe organ dysfunction or brain metastases.
- Must be postmenopausal, verified by age, surgical history, or hormone levels.
- No more than two prior chemotherapy treatments for metastatic cancer.
- Must not have had tamoxifen treatment in the metastatic setting.
- Must not be taking strong inhibitors of certain liver enzymes or other investigational drugs.
- Must not have uncontrolled illnesses or certain eye conditions.
- Must not have had a deep vein thrombosis or pulmonary embolism in the past 6 months unless stable on treatment.
- Must not have another active cancer within the past 3 years, except for certain skin cancers.
- Must be able to swallow pills and have adequate blood counts and organ function.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Southern Cancer Center PC-Providence | 36608 | Mobile | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Regional Hospital | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
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