Aromasin (Exemestane) - Summary

AROMASIN SUMMARY

AROMASIN® Tablets for oral administration contain 25 mg of exemestane, an irreversible, steroidal aromatase inactivator.

AROMASIN is indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy.

AROMASIN is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

See all Aromasin indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Aromasin (Exemestane)

FDA Approves Abemaciclib (Verzenio) for Advanced HR+ Breast Cancer
Source: Medscape Hematology-Oncology Headlines [2017.09.28]
The new drug is similar to two other cyclin-dependent kinase (CDK) 4/6 inhibitors, but it also has some distinguishing qualities.
FDA Approvals

Breast Cancer Radiation 'Less Scary' Than Thought
Source: MedicineNet Cancer Specialty [2017.09.26]
Title: Breast Cancer Radiation 'Less Scary' Than Thought
Category: Health News
Created: 9/25/2017 12:00:00 AM
Last Editorial Review: 9/26/2017 12:00:00 AM

Exercise After Breast Cancer Surgery Clears 'Brain Fog'
Source: Medscape General Surgery Headlines [2017.09.25]
Increased daily aerobic activity triples processing speed on both objective and self-rated cognition tests in previously sedentary breast cancer survivors.
Medscape Medical News

Yoga May Bring Better Sleep to Breast Cancer Patients
Source: MedicineNet Chemotherapy Specialty [2017.09.22]
Title: Yoga May Bring Better Sleep to Breast Cancer Patients
Category: Health News
Created: 9/22/2017 12:00:00 AM
Last Editorial Review: 9/22/2017 12:00:00 AM

Breast Cancer Quiz: Symptoms & Signs
Source: MedicineNet Breast Lumps In Women Specialty [2017.09.19]
Title: Breast Cancer Quiz: Symptoms & Signs
Category: MedicineNet Quiz
Created: 10/11/2010 12:00:00 AM
Last Editorial Review: 9/19/2017 5:02:57 PM

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Published Studies Related to Aromasin (Exemestane)

Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis. [2013]
this patient population... CONCLUSION: The addition of everolimus to exemestane markedly prolonged PFS in

Randomized phase II, double-blind, placebo-controlled study of exemestane with or without entinostat in postmenopausal women with locally recurrent or metastatic estrogen receptor-positive breast cancer progressing on treatment with a nonsteroidal aromatase inhibitor. [2013]
alone... CONCLUSION: Entinostat added to exemestane is generally well tolerated and

Health-related quality of life of patients with advanced breast cancer treated with everolimus plus exemestane versus placebo plus exemestane in the phase 3, randomized, controlled, BOLERO-2 trial. [2013]
(HRQOL)... CONCLUSIONS: In patients with advanced breast cancer who develop disease

Ganitumab with either exemestane or fulvestrant for postmenopausal women with advanced, hormone-receptor-positive breast cancer: a randomised, controlled, double-blind, phase 2 trial. [2013]
hormone-receptor-positive breast cancer... INTERPRETATION: Addition of ganitumab to endocrine treatment in women with

Bone density and structure in healthy postmenopausal women treated with exemestane for the primary prevention of breast cancer: a nested substudy of the MAP.3 randomised controlled trial. [2012]
of potential widespread use, we examined the safety of exemestane on bone health... INTERPRETATION: 2 years of treatment with exemestane worsens age-related bone

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Clinical Trials Related to Aromasin (Exemestane)

Aromasin� Non-Interventional Study Of Early Invasive Breast Cancer Patients In China [Recruiting]
Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years of tamoxifen & are switched to Aromasin® for completion of a total of 5 consecutive years of adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since then, there is currently lack of systematic collection and analysis for the efficacy and safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin® Non-Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population.

An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin [Terminated]
To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India.

- Efficacy of the treatment with Aromasin®

- Safety of the treatment with Aromasin®

A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin�) In Postmenopausal Hr+ Patients [Terminated]
Observational survey aiming to evaluate the tolerability of Aromasin and the ways in which it is used in clinical practice in France (as adjuvant endocrine therapy).

Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding [Completed]
The purpose of this study is to assess the efficacy, safety and tolerability of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal aromatase inhibitor (AI).

Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer [Completed]
The primary goal of this 5-year study is to determine whether exemestane alone or in combination with celecoxib decreases breast tissue density in healthy postmenopausal women at high risk for breast cancer. Dense breast tissue seen on mammography has been linked to an increased risk of breast cancer. The study will also examine the effects of exemestane and celecoxib on bone density, blood hormone levels and quality of life. Exemestane, approved by the Food and Drug Administration for treating postmenopausal women with breast cancer, lowers the amount of estrogen in the body. Celecoxib, approved for treating arthritis pain and for reducing the number or colon polyps in an inherited syndrome, is an anti-inflammatory drug. Half of the women in the study will receive exemestane alone and half will receive exemestane and celecoxib together. In December 2004, the arm using exemestane and celecoxib was closed to accrual Postmenopausal women who are at increased risk for developing invasive breast cancer may be eligible to participate. Candidates are screened with breast cancer risk assessment, medical history and physical examination, blood tests, review of medical records, if needed, breast biopsy, and dual energy x-ray absorptiometry (DEXA) scan to assess bone density. For the DEXA scan, the subject lies still on a table for about 30 minutes while the spine and hip are scanned using a small amount of radiation. Participants take exemestane in pill form once a day for 2 years. They also take calcium and vitamin D pills daily to help protect bone health. They are followed in the clinic during the course of the study to determine the amount of drug taken and any side effects, and for the following tests and procedures:

- Medical evaluation and blood tests at after 1 and 3 months on study drugs

- Medical evaluation at 6 months

- Breast biopsy at screening and then at 12 months

- dual-emission x-ray absorptiometry (DEXA) scan of the spine, mammogram and routine

blood tests before starting study drugs and then yearly for 5 years.

more trials >>

Reports of Suspected Aromasin (Exemestane) Side Effects

Arthralgia (31),  Alopecia (20),  Disease Progression (19),  Breast Cancer (18),  Fatigue (14),  Pain (13),  Abdominal Distension (12),  Rash (12),  Bone Pain (11),  Headache (11), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Aromasin review by 57 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Breast Cancer
Dosage & duration:		5mg taken 1/day for the period of 3 years
Other conditions:		under-active thyroid
Other drugs taken:		Synthroid
		Reported Results
Benefits:		Aromasin's treatment benefits are unknown. I have not had a reoccurance of breast cancer while on the drug, though unsure we can attribute that with the drug treatment itself. Perhaps there are other positive health-related items coming into play, such as exerciase and eating habits. Not aware of any side effects or adverse reactions. Drug is very expensive, however.
Side effects:		As mentioned above, I have not had any side effects from Aromasin other than hot flashes and night sweats. These may be due to menopause rather than the treatment itself. The hot flashes have been relatively mild and can be controlled, for the most part, by limiting or removing all alcoholic beverages.
Comments:		After breast cancer treatment of chemo. and radiation I was put on Tamoxifen for several years, about 5 years. After Tamoxifen, it was recommended that I start taking Aromasin, which I have done for about 3 years. My doctor said it is not known how long women should be on Aromasin and still receeve a benefit from taking the drug.

Aromasin review by 58 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		eostrogen-positive breast cancer
Dosage & duration:		25mg taken daily for the period of 4 years
Other conditions:		high blood pressure
Other drugs taken:		various blood pressure medications
		Reported Results
Benefits:		During the 4 years so far [out of 5], I have had no recurrance of the tumour and no additional tumours have been detected by ultra-sound, mammogram, and twice-yearly check-ups. Perhaps the greatest benefit is the gradual reduction in stress experienced as a result of my on-going stabilised condition after a lumpectomy.
Side effects:		I had some initial swelling of my hip, knee and ankle joints in the morning which slowly subsided during the day. The medication also aggravated the hot-flushes of the menopause, making them initially frequent and copious, and on-going for the treatment duration so far - tho with reduced frequency now in Year 4. I also experience considerable thirst.
Comments:		I was put on Aromasin after 6 months on Tamoxifen because I suffered debilitating muscle cramps on Tamoxifen as well as joint problems and extreme hot flushes. Aromasin has been kinder, and so far I have taken it daily for 4 years out of an initial 5. It may be prescribed beyond 5 years, I'm not sure. It has relatively slight side effects now but in the first 6 months I was conscious of its effects on my body - not intolerable by any means, just noticable.