Breast cancer survivors
Women under 45
Women over 45
Special populations: Young breast cancer survivors who have gone through menopause
Hormonal therapy reduces the risk of recurrence for women with early-stage breast cancer that is ER-and/or PR-positive. Standard therapy lasts 5 years. A new study looks at whether extending one type of hormonal therapy, known as aromatase inhibitor therapy, to 10 years lowers recurrence rates even more for these women. (7/26/16)
|At a glance||In-depth|
|Questions for your doctor||Resources and references|
Whether patients will benefit (lower risk of recurrence or new breast cancer in the other breast) if they stay on aromatase inhibitor therapy for 10 years rather than the standard 5 years.
According to the lead author of this research study, patients with early-stage breast cancer live for a long time, but “face an indefinite risk of relapse.”
This data suggests that extending aromatase inhibitor therapy to 10 years instead of stopping it at 5 may improve patient outcomes. Women who were on aromatase inhibitor therapy for 10 years did not have recurrences or develop new cancers in the other breast, although the difference between the 5-year and 10-year groups was relatively low. Women on 10 years of aromatase inhibitors experienced more side effects related to bone density and fractures. Women should have a risk/benefit conversation with their healthcare providers to discuss if extending aromatase inhibitor therapy is right for them. Patients also need to consider the side effects of aromatase inhibitors and the cost of the drug.
In 2018, the American Society of Clinical Oncology (ASCO) published updated guidelines on endocrine treatment (hormonal therapy) for women with ER/PR-positive breast cancer. The guidelines recommended:
The guidelines also noted the following to inform the decision-making process:
NCT03822715: NEOBREADS: Neoadjuvant Breast Diet Study (NEOBREADS). This is a trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via phone counseling with dietitian plus aromatase inhibitor therapy vs. 6-month control with aromatase inhibitor therapy alone. Visits will occur at screening, 3 months, and 6 months.
NCT03219476: Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive HER2-Negative Node-Negative Breast Cancer Patients to Assess Responses and Mechanisms of Endocrine Resistance. This is an exploratory interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for four weeks.
NCT01723774: PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer. A study to investigate PD 0332991 in the treatment of early stage ER+/HER2-negative breast cancer, to investigate whether the combination of PD 0332991 and anastrozole is able to: 1) improve the pathologic complete response rate when compared to the historical control of single agent aromatase inhibitors, 2) result in fewer patients with on therapy Ki67>10% compared to historical control.
NCT03518138: Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor. This is a Phase 2 designed to determine the effectiveness of Q-122 versus placebo to treat hotflashes in women taking tamoxifen or an aromatase inhibitor.
NCT04086875: A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer. This trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage I-III hormone receptor positive breast cancer.
NCT03865992: Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease. This phase I trial studies how well curcumin works in reducing joint pain in patients who are breast cancer survivors and have joint disease caused by treatment with aromatase inhibitors. Curcumin is an ingredient of turmeric, a plant in the ginger family, which is commonly used in cooking, and may decrease joint pain in patients with arthritis from other conditions.
Clinical Oncology News
Researchers of this current study explored whether extending the length of time women took the aromatase inhibitor provided additional benefit. Paul Goss and his colleagues at Massachusetts General Hospital and other institutions presented their data on this new clinical trial (MA.17R) at the 2016 American Society of Clinical Oncology Meeting, Their observations of what happens when women take an aromatase inhibitor for 10 years instead of 5 were also published in The New England Journal of Medicine.
This study follows previous research showing that taking an aromatase inhibitor (Letrozole) after 5 years of tamoxifen improved disease-free survival.
Whether patients who stay on an aromatase inhibitor for 10 years have fewer recurrences and develop fewer new breast cancers than patients who take aromatase inhibitors for 5 years.
The study enrolled 1,918 postmenopausal women who had estrogen receptor (ER)- and/or progesterone receptor (PR)-positive, early-stage breast cancer.
Women in the study fell into 1 of 3 groups:
Among the 3 groups of women, some were randomized to receive another 5 years of AI therapy (Letrozole) or 5 years of receiving a placebo.
This research did not take genetic status into account, so how women with mutations in BRCA or other genes that increase cancer risk respond to an additional 5 years of aromatase inhibitor therapy is unknown. Some patients involved in the study had previously taken tamoxifen, while some had not. From the data presented, it is not known if the use of tamoxifen before an aromotase inhibitor affected a patient’s risk of recurrence or new cancer. Finally, a number of aromatase inhibitors are available, and not all women in the study took the same aromatase inhibitor for the first 5 years.
The results of this study suggest that taking an aromatase inhibitor for 10 years instead of 5 may benefit ER- and/or PR-positive breast cancer patients. But there was no increase in overall survival between women who took aromatase inhibitors for 5 years and those who took aromatase inhibitors for 10 years. Patients should discuss with their health care provider all the risks and benefits when thinking about extending their aromatase inhibitor for longer than 5 years.
Share your thoughts on this XRAYS article by taking our brief survey.