Study: Does extending hormonal therapy impact risk of breast cancer recurrence?
Hormonal therapy significantly reduces the risk of recurrence for women with early-stage estrogen receptor-positive breast cancer. Standard hormonal therapy is given for 5 years; extending that therapy for a longer period offers additional protection but has added side effects. This study looked at women who stopped hormonal therapy after 5 years and identified factors that may guide the decision to extend treatment. (12/21/17)
Contents
At a glance | In-depth |
Findings | Limitations |
Clinical trials | Resources |
Questions for your doctor |
STUDY AT A GLANCE
This study is about:
- Identifying which patients with ER-positive breast cancer could safely stop endocrine (hormonal) therapy (thereby avoiding the side effects) after 5 years because their risk for long-term distant recurrence was "so small”
- Factors that may influence whether or not to extend hormonal therapy beyond 5 years for women with early-stage estrogen receptor- (ER-) positive breast cancer.
Why is this study important?
Standard treatment for early-stage breast cancer often includes 5 years of endocrine-based (hormonal) treatments such as tamoxifen or aromatase inhibitors (both are pills that are taken daily). The aim of this study was to learn which patients could stop hormonal therapy after 5 years because their risk of recurrence would be very small. However, this study found that even for women believed to be at low risk of recurrence, breast cancer recurrences continued steadily for up to 20 years after diagnosis. This study identified which features of a patient’s original cancer influence long-term risk of recurrence. These findings may help guide the decision of whether or not to extend standard hormonal therapy beyond 5 years.
Study findings:
In women diagnosed with early-stage ER-positive breast cancer who stopped endocrine therapy after the standard 5 years of treatment, breast cancer recurrence occurred at a steady rate from 5 to 20 years. Over the study period, risk of recurrence was strongly linked to the original cancer's size and to the number of positive at the time of diagnosis.
- Among women with early-stage T1(2 cm or less) breast cancer, risk of recurrence was:
- 13% for those with no positive lymph nodes
- 20% for those with 1 to 3 positive lymph nodes
- 34% for those with 4 to 9 positive lymph nodes
- Among women with early-stage T2 (larger than 2 cm but less than 5 cm) breast cancer, risk of recurrence was:
- 19% for those with no positive lymph nodes
- 26% for those with 1 to 3 positive lymph nodes
- 41% for those with 4 to 9 positive lymph nodes
What does this mean for me?
The results of this study may help identify which early-stage ER-positive breast cancer patients would most benefit from extending hormonal therapy beyond the standard 5 years of treatment. However, the benefits of extending endocrine therapy must be weight against side effects. The findings of this study underline the need to help women who are receiving endocrine therapy to discover whether any side effect symptoms are actually caused or made worse by therapy.
Posted 12/21/17
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In 2019, the American Society of Clinical Oncology (ASCO) published updated guidelines on endocrine treatment (hormonal therapy) for women with breast cancer. The guidelines recommended:
- Women with node-positive breast cancer should receive extended therapy, including an aromatase inhibitor, for up to a total of 10 years of endocrine treatment.
- Women with node-negative breast cancer should consider extended therapy for up to a total of 10 years of adjuvant endocrine treatment based on considerations of their risk for recurrence.
- The decision to extend or not extend hormone therapy should be a shared decision between doctors and patients based on discussions that weighs the benefits of lowering the risk for breast cancer recurrence and preventing second breast cancers versus the negative impact of treatment side effects.
The ASCO Panel notes that the benefits of reduction are small and that a substantial portion of the benefit for extended adjuvant aromatase inhibitor therapy comes from preventing a new breast cancer diagnosis.
Updated: 01/02/2022
- Would I benefit from extending hormonal therapy beyond the standard 5 years?
- What are the side effects and of hormonal therapies like tamoxifen?
- What are the side effects and toxicity of aromatase inhibitors?
- What are the added side effects of extending hormonal therapy beyond 5 years?
The following studies are enrolling people with early-stage ER-positive, breast cancer.
- NCT03053193: MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles (FLEX). The FLEX Registry will be a large-scale, population-based, registry. All patients with 1-3 breast cancer who receive MammaPrint and BluePrint testing on a primary breast tumor are eligible for this registry.
- NCT05607004: (Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer (EVANGELINE). This study looks at the drug (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen is a type of hormone therapy that blocks the body's natural from binding to cancer cells.
- NCT04584255: Treating Early-Stage HER2-Negative Breast Cancer with a () and (Dostarlimab) in People with a or Mutation. This study looks at how well the PARP inhibitor niraparib and the immunotherapy drug dostarlimab treat early-stage breast cancer in people with an inherited , or PALB2 mutation.
- NCT03749421: Prosigna Assay on Clinical Decision-making in Women With HR+/Her2- Breast Cancer. This study evaluates a genomic analysis called Predictor Analysis of Microarray 50 (PAM50, by Prosigna®) as a tool that guides participants and treating physicians for choose the most personalized pre-operative treatment for breast cancer.
- NCT04567420: DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage II-III, Hormone Receptor Positive, HER2 Negative Breast Cancer. This study monitors people with early-stage, high-risk breast cancer for possible recurrence using a test called circulating tumor (). People who test positive for ctDNA but have no other signs of recurrence will receive either the drugs palbociclib combined with fulvestrant or standard-of-care adjuvant hormone therapy.
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NCT04852887: De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA). This study evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
Several other clinical trials for patients with early-stage breast cancer can be found here.
Updated: 02/01/2024
The following organizations offer peer support services for people with or at high risk for breast cancer:
- FORCE peer support:
- Our Message Boards allow people to connect with others who share their situation. Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Our Peer Navigation Program will match you with a volunteer who shares your mutation and situation.
- Connect online with our Private Facebook Group.
- Join our virtual and in-person support meetings.
- Other organizations that offer breast cancer support:
Updated: 05/07/2024
Who covered this study?
NBC News
Breast cancer may return even 20 years later, study finds
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Healthline
Long haul for breast cancer survivors: disease can return after 20 years
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Modern Medicine Network
Risk of breast cancer recurrence can last up to 20 years
This article rates 3.5 out of
5 stars