Aromasin vs Tamoxifen: The IES Trial and FDA Labels
[Breast cancer · Hormone therapy · Comparison]

Aromasin vs tamoxifen: how do the two breast cancer tablets differ?

Approved uses · Dose · IES side effects · Warnings

Short answer: Both treat hormone receptor-positive breast cancer.12 Aromasin (exemestane) is approved for postmenopausal women, after 2 to 3 years of tamoxifen to complete 5 years, or for advanced cancer after tamoxifen. Tamoxifen also covers men, DCIS and risk reduction. In IES, reported in the Aromasin label, joint pain was more common on Aromasin, and clots and uterine changes on tamoxifen. Only tamoxifen has a boxed warning.

How do Aromasin and tamoxifen compare side by side?

From the US Aromasin label and the generic tamoxifen citrate label (Mylan). The IES rows come from a trial that compared the two directly in postmenopausal women with early breast cancer after earlier tamoxifen.
AromasinTamoxifen
Approved forPostmenopausal women: estrogen receptor-positive early breast cancer after 2 to 3 years of tamoxifen, and advanced breast cancer that progressed after tamoxifen1Metastatic breast cancer in women and men, treatment after surgery, lowering invasive cancer risk after DCIS, and lowering breast cancer incidence in high-risk women2
Label dose25 mg once daily after a meal; 50 mg with a strong CYP3A4 inducer120 to 40 mg daily for breast cancer, doses above 20 mg split morning and evening; 20 mg daily for 5 years for DCIS and risk reduction2
IES: hot flushes21%120%1
IES: joint pain15%19%1
IES: trouble sleeping12%19%1
IES: osteoporosis / clinical fractures4.6% / 4.2%12.8% / 3.1%1
IES: heart events from reduced blood flow1.6%10.6%1
Boxed warningNone1Uterine cancers, stroke and pulmonary embolism in women using it after DCIS or to lower breast cancer risk2

Reviewed . Half-life figures are shown only where the value Dose Track uses agrees with the cited source.

What did IES show about side effects?

IES compared Aromasin 25 mg daily (2,252 women) with tamoxifen 20 mg daily (2,280 women) in postmenopausal women with early breast cancer.1 Beyond the table above, carpal tunnel syndrome was 2.4% vs 0.2%, tingling 2.6% vs 0.9% and diarrhea 4.2% vs 2.2%; tamoxifen had more muscle cramps, blood clots, endometrial hyperplasia and uterine polyps. Lumbar spine bone density changed -3.1% on Aromasin vs -0.2% on tamoxifen at 24 months. Stopping because of side effects was 6% vs 5%.1

How do the warnings differ?

Tamoxifen has a boxed warning for women using it after DCIS or to lower breast cancer risk: in the P-1 trial, endometrial cancer was 2.20 vs 0.71 per 1,000 women-years on placebo, stroke 1.43 vs 1.00 and pulmonary embolism 0.75 vs 0.25. The label says the benefits outweigh these risks in women already diagnosed with breast cancer.2 The Aromasin label warns about bone loss, asks for a vitamin D check before starting, says not to take it with estrogen-containing medicines, and says it is not for women before menopause.1

Which, if either, fits is for your prescriber. More detail: Aromasin side effects, tamoxifen side effects, the Aromasin and tamoxifen dosing schedules, the tamoxifen missed-dose page, Arimidex vs tamoxifen: how do the two breast cancer tablets differ? and Femara vs tamoxifen: how do the two breast cancer tablets differ?.

Frequently asked questions

Have Aromasin and tamoxifen been compared directly?+
Yes. The Aromasin label reports IES, which compared Aromasin 25 mg with tamoxifen 20 mg in about 4,500 postmenopausal women with early breast cancer.1
Is Aromasin taken after tamoxifen?+
For early breast cancer, yes. The label describes switching to Aromasin after 2 to 3 years of tamoxifen to complete 5 years of hormone therapy in total.1
What if I miss a dose?+
The Aromasin label has no missed-dose instruction, so ask your prescriber or pharmacist. The tamoxifen Medication Guide says to take it when you remember, and not to take extra tablets if it is almost time for the next dose.12
Can Dose Track remind me to take them?+
Yes. You can log each dose and set a reminder.