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SWOG RxPONDER Trial (S1007): Patient Information
RxPONDER: a clinical trial. Rx for Positive Node, Endocrine Responsive Breast Cancer

RxPONDER Resources

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Taking part in RxPONDER

Thank you for your interest in the RxPONDER (riz-POND-er) clinical trial.

RxPONDER's goal is to help doctors and their patients with breast cancer make better treatment decisions by using a genomic test known as the Oncotype DX® Assay.

Patients with hormone receptor-positive breast cancer that has spread to their lymph nodes usually get both chemotherapy and hormonal therapy after surgery. But for some of these patients with low to intermediate "recurrence scores" on the Oncotype DX test, chemotherapy may offer little or no benefit. Hormonal therapy alone may be enough.

RxPONDER will measure just how much, if any, benefit these patients get from chemotherapy. And it will try to determine where the cutoff score is between patients who benefit from chemotherapy and patients who do just as well with hormonal therapy alone.

This web page does not replace the study's informed consent form or information from your study doctor.

What is a clinical trial?
A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective, and to answer questions that will improve cancer care.
What question does RxPONDER hope to answer?

RxPONDER (also known as SWOG S1007) is designed primarily to answer this question:

For patients with node-positive, hormone-receptor positive, HER2 negative breast cancer who also have low to intermediate Oncotype DX recurrence scores, what are the benefits -- if any -- from adding chemotherapy to hormonal therapy after surgery?

Why is it important to answer this question?
The short answer is this: So patients don't get chemotherapy they don't need.

Patients with node-positive breast cancer generally get chemotherapy as a standard part of their treatment following surgery (also called adjuvant treatment). But many of these patients see little added benefit from that chemotherapy; for many patients, hormonal therapy is enough.

If we can use a test to predict who will benefit from chemotherapy and who is unlikely to benefit, we can save some patients from the serious side effects and the cost of a course of chemotherapy treatment they don't need.

Who can take part in the RxPONDER trial?
You may be eligible to take part in RxPONDER if
  • you are a woman with early breast cancer and have had or will have surgery,
  • your cancer is hormone-receptor positive,
  • your cancer is HER2-negative,
  • your cancer has been found in from 1 - 3 of your lymph nodes, and
  • you have not yet begun chemotherapy or hormonal therapy for your cancer.
What will happen in the study?
If you agree to take part, some of your tissue that was removed at surgery will be tested with the Oncotype DX Assay. This is Step 1. If the result of that test is a recurrence score of 25 or lower, you will be eligible to continue with Step 2 of the study.

If your recurrence score is higher than 25, you will be finished with your contributions to this trial. You and your doctor will decide the best course of treatment, and you may be able to identify other clinical trials you can take part in.

What will happen in Step 2 of the study?
If your recurrence score is 25 or lower, you will be placed at random into one of two study groups:
  • Arm 1: treated with chemotherapy and hormonal therapy
  • Arm 2: treated with hormonal therapy
Your chance of being placed into Arm 1 is equal to your chance of being placed into Arm 2. In each case, that chance is fifty percent. Keep in mind that doctors do not yet know whether the treatment in one arm is better than the other for those with your type of cancer. Once you have been "randomized," you and your doctor will be told which study arm you have been placed in. schematic diagram showing randomization of patients into arm 1 or arm 2

If you are in Arm 1:
Your doctor will first prescribe you chemotherapy. There are a number of chemotherapy drugs and drug combinations that are considered "standard of care" and are options in this trial. You and your doctor will decide which chemotherapy option is best for you.

You will then have hormonal therapy (also called endocrine therapy). This therapy might include ovarian suppression drugs if you are premenopausal, aromatase inhibitors if you are postmenopausal, or drugs such as tamoxifen that block estrogen receptors in the body. You and your doctor will choose the hormonal therapy that is best for you.

If you are in Arm 2:
Your doctor will prescribe you a course of hormonal therapy only (as described in Arm 1 above). You will not get chemotherapy.

What is the Oncotype DX Breast Cancer Assay? How is it done?
Lab researchers will examine a small sample of the tissue that was removed during your breast cancer surgery. They will analyze a group of 21 genes -- 16 cancer related genes and 5 control genes -- to see how active they are, or their "expression pattern." The results of the test will be reported as a recurrence score between 0 and 100. Studies have shown that the higher this recurrence score, the more likely it is that a patient's cancer will return.

Other studies have shown that in some cases doctors can use this recurrence score to determine how likely it is that a patient will benefit from adding chemotherapy to hormonal therapy. RxPONDER should answer questions about how to use the recurrence score in this way for patients with node-positive breast cancer.

The Oncotype DX Breast Cancer Assay is performed by Genomic Health, Inc. of Redwood City, California. The test has been used to evaluate tumors and inform treatment decisions for more than 175,000 breast cancer patients since 2004.

What benefits will I see from participating in this study?
You will probably not see any extra benefit from participating in this trial. The treatments used in both arms are among the standard regimens that will be used to treat your type of breast cancer even if you do not enroll in this trial.

The benefits from the trial will be realized by women who develop breast cancer in the future and who have more targeted, effective treatment options to prolong and improve their lives because of your participation. You may help keep some women from a difficult course of chemotherapy that's not necessary. You may help ensure other women get the chemotherapy that will prolong their lives. Just as most of the treatments you benefit from today were developed in clinical trials with past patients, future patients would see the benefits of your contributions.

What are the risks of participating in the study?
Most of the risks of participating are the risks posed by chemotherapy and hormonal therapy. Common side effects from chemotherapy include hair loss, nausea or vomiting, fatigue or dizziness, tingling or numbness in hands and feet, heightened risk of infection, and difficulty concentrating.

Common side effects from hormonal therapy include joint pain, increased cholesterol levels, nausea, and menopausal symptoms such as hot flashes, vaginal dryness, and mood swings. Both chemotherapy and hormonal therapy can also cause infertility.

Remember that these side effects are risks from treatment of the cancer. You are likely to encounter them whether you participate in this study or not. Your doctor will discuss with you the specific risks of the course of treatment you choose.

What if I decide I would like to stop participating?
You can leave the trial at any time. Simply tell your doctor you plan to stop participating so he or she can tell you how to stop safely.
Would being on this study change the cost of my care?
Taking part in the trial probably will not significantly change the cost of your care, but we can't say that for sure.

The treatments and routine tests done within Rx- PONDER are considered part of standard care for your condition, and you or your insurance company will be billed (just as if you were not in a clinical trial). Insurance companies and Medicare generally cover the routine costs of care required in clinical trials, but coverage varies from plan to plan.

The National Cancer Institute's website has more information on clinical trials and insurance coverage.

Will I have to pay for the Oncotype DX test?
No, if you were registered to the study before the test was ordered. The Oncotype DX Breast Cancer Assay is an approved diagnostic test in the U.S. The cost will be billed to your insurance company. Genomic Health will work with insurance companies directly to get reimbursed for the test.

If you were registered for this study before the test was ordered, you will not be charged for the cost of the test even if your insurance company does not pay for all or part of it, or if you can not afford health insurance. If you were registered for this study after the test was ordered, you may receive a bill for all or part of the cost of the test.

You may receive an Explanation of Benefits (EOB) statement from your insurance company letting you know that a claim has been submitted on your behalf. But you won't receive a bill from Genomic Health for the test cost or for a deductible or co-pay amount.

If you have questions or concerns about a statement you get from your insurance company for the Oncotype DX Assay or about Genomic Health's billing policies, please call Genomic Health at 1-866-ONCOTYPE (1-866-662-6897) toll-free.

Funding to help offset patient costs for the Oncotype DX test is being provided through a cost-sharing agreement between The Hope Foundation (SWOG's philanthropic arm) and Genomic Health.

Who is conducting this clinical trial?
Most of the major National Cancer Institute (NCI)- supported cooperative groups are collaborating to conduct RxPONDER. The trial is designed and coordinated by one of those groups, SWOG (formerly the Southwest Oncology Group).

SWOG is a network of more than 4,000 cancer researchers at more than 500 institutions across the country and beyond. Its mission is to improve the practice of medicine in preventing, detecting, and treating cancer and to enhance the quality of life for cancer survivors.

Since the 1950s, more than 200,000 participants have enrolled in SWOG-led cancer clinical trials. The advances in treatment and prevention that have come from those trials have improved the lives and health care of millions more.

Where is this trial open?
The trial will be opened at hundreds of sites all across the country. Here's a list of SWOG institutions that have the site open. You can also find a list of additional non-SWOG sites with the trial open at the clinicaltrials.gov site (scroll down to the "Contacts and Locations" section).
Where can I learn more?
Your study doctor can answer questions and give you an informed consent document with more information about the RxPONDER trial. You can learn more from the sources below.

These resources are available on the website of the National Cancer Institute:

You may find these additional resources helpful:

This brochure is meant as a patient's introduction to the RxPONDER breast cancer clinical trial. It does not replace the study's detailed informed consent form or information from your study doctor.

More about SWOG

This study is designed and conducted by the Southwest Oncology Group, or SWOG, a National Cancer Institute-supported network of more than 4,000 cancer researchers at more than 500 institutions in the U.S., Canada, and beyond.

SWOG works to improve the practice of medicine in preventing, detecting, and treating cancer and to improve the quality of life for cancer survivors.

Since the 1950s more than 200,000 participants have enrolled in SWOG-led cancer clinical trials. The advances in treatment and prevention that have come from those trials have improved the lives and health care of millions more.

Learn more at swog.org.

 

The content on this page has been reviewed and approved for patient use by the Central Institutional Review Board (CIRB) of the National Cancer Institute (NCI).

S1007 protocol rev2 20110719 (updated 20120724)

 
     
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