This trial is currently seeking participants.
Researchers seek 4,000 participants for a clinical trial that will study whether hormonal therapy alone is adequate treatment for early-stage invasive breast cancer that traveled to one to three axillary lymph nodes and is found to be of low or intermediate risk for recurrence by genomic tests. Axillary lymph nodes are lymph nodes located in the armpit.
Whether hormonal therapy alone is enough treatment to protect from recurrence remains an important issue for breast cancer researchers. Chemotherapy can be costly financially, physically and emotionally, and learning more about which cancers truly need it could save women from getting unnecessary treatment.
Study Background and Goals
Estrogen fuels the growth of cancer cells in many hormone-sensitive breast cancers. Treatments that block estrogen, called hormonal therapies, may slow or stop the growth of tumor cells by stalling the work of estrogen or by lowering the level of estrogen in the body. Chemotherapy, a standard treatment for many kinds of cancer, works to stop cancer growth by preventing cancer cells from dividing or by killing them.
This study’s main goal is to measure the usefulness of chemotherapy in hormone positive tumors with a Recurrence Score of 0-25. Cancers will be tested using Oncotype DX, a genomic test that looks at groups of genes in cancer cells to see the level of activity and predict how the cancer grows and responds to therapy. Recurrence Scores of less than 18 are considered to be at low risk for recurrence; those from 18 to 25 are intermediate risk.
Other goals include comparing the groups for overall survival and side effects. Researchers will collect information on the impact of tests on participants’ treatment decisions and self-reported levels of anxiety.
This trial will also look at the effectiveness of PAM50, a genomic test under study, to see how it compares to Oncotype DX at predicting survival.
Structure of Study
Participants will have Oncotype DX performed on a sample of their tumor. If the Recurrence Score is between 0 and 25, the participants will be randomly assigned to one of two arms:
- Arm 1: a standard chemotherapy regimen plus hormonal therapy
- Arm 2: a standard hormonal therapy alone
All the hormonal therapies are taken in pill form, while the chemotherapy is given by vein.
After study treatment is over, participants will be followed every three months for two years, every six months for three years, and then yearly for at least 15 years.
Eligibility
You may be able to take part in this study if you:
- Are a woman 18 years or older, pre- or post-menopausal
- Have confirmed invasive breast cancer with cancer that tests positive in one to three lymph nodes
- Have estrogen receptor-positive (ER+) or progesterone receptor-positive (PR+) breast cancer, or both, or HER2 negative breast cancer
- Have a Recurrence Score by Oncotype DX of 25 or less
- Do not have inflammatory or metastatic breast cancer
- Had lumpectomy with planned radiation therapy or a mastectomy with clear margins within the last 56 days
- Have never received chemotherapy or hormonal therapy for breast cancer
- Have not received tamoxifen or raloxifene as preventive treatment
- Have never had breast radiation treatment
Study Locations
This study is being carried out at 688 locations in the United States, Canada, Korea, Mexico and Puerto Rico. For a full listing of locations with local contact information, see trial NCT01272037 on ClinicalTrials.gov or the link below.
S1007 on ClinicalTrials.gov
