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Femara (Letrozole) - Summary

 



FEMARA SUMMARY

Femara® (letrozole tablets) for oral administration contains 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis).

Femara® (letrozole tablets) is indicated for first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. Femara is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.


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NEWS HIGHLIGHTS

Media Articles Related to Femara (Letrozole)

Femara vs. Tamoxifen for Breast Cancer
Source: MedicineNet Breast Cancer Questions To Ask The Doctor Specialty [2009.08.20]
Title: Femara vs. Tamoxifen for Breast Cancer
Category: Health News
Created: 8/20/2009
Last Editorial Review: 8/20/2009

Secretary Sebelius Statement On New Breast Cancer Recommendations
Source: Health News from Medical News Today [2009.11.19]
HHS Secretary Kathleen Sebelius issued the following statement today on new breast cancer screening recommendations from the U.S. Preventive Services Task Force: "There is no question that the U.S. Preventive Services Task Force Recommendations have caused a great deal of confusion and worry among women and their families across this country. I want to address that confusion head on. The U.S.


Breast Cancer Campaign: New Breast Cancer Research Funding For Belfast
Source: Health News from Medical News Today [2009.11.19]
Individualised radiotherapy treatment based on a person's genetic make up could soon become a reality, according to Breast Cancer Campaign. Professor Kevin Prise from Queen's University Belfast has been awarded a three year project grant by the charity to study how genes are involved in the effectiveness of radiotherapy treatment for breast cancer.


Some Physicians Say New Breast Cancer Screening Guidelines Unlikely To Alter Their Practices
Source: Health News from Medical News Today [2009.11.19]
One day after the release of new breast cancer screening guidelines, many physicians and some medical groups are saying that they do not plan to adopt the new recommendations -- which represent a drastic change -- the New York Times reports (Belluck, New York Times, 11/18). The guidelines, released by the U.S.


Radiation Breakthrough Gives Breast Cancer Patients Hope In Single Dose
Source: Breast Cancer News From Medical News Today [2009.11.19]
A radiation breakthrough to treat breast cancer patients in one day, as opposed to the current average of six weeks, has arrived at Cancer Treatment Centers of America(R) (CTCA) in Philadelphia. CTCA will become the first in the country to offer this treatment option using the Novac7 technology from Rome, Italy.

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Published Studies Related to Femara (Letrozole)

Letrozole versus combined metformin and clomiphene citrate for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a randomized controlled trial. [2009.09.02]
OBJECTIVE: To compare the effect of letrozole with combined metformin and clomiphene citrate (CC) for ovulation induction in CC-resistant women with polycystic ovary syndrome (PCOS)... CONCLUSION(S): Letrozole and combined metformin-CC are equally effective for inducing ovulation and achieving pregnancy in patients with CC-resistant PCOS .

Endocrine effects of adjuvant letrozole compared with tamoxifen in hormone-responsive postmenopausal patients with early breast cancer: the HOBOE trial. [2009.07.01]
PURPOSE We compared the endocrine effects of 6 and 12 months of adjuvant letrozole versus tamoxifen in postmenopausal patients with hormone-responsive early breast cancer within an ongoing phase III trial. PATIENTS AND METHODS Patients were randomly assigned to receive tamoxifen, letrozole, or letrozole plus zoledronic acid...

Letrozole administration during the luteal phase after ovarian stimulation impacts corpus luteum function: a randomized, placebo-controlled trial. [2009.07]
OBJECTIVE: To investigate the effect of letrozole-an oral aromatase inhibitor-on E(2), P, and LH levels when administered during the luteal phase after oocyte retrieval in IVF/intracytoplasmic sperm injection (ICSI) cycles.This may be of interest not only for egg donors, but also in patients at high risk of ovarian hyperstimulation syndrome (OHSS) who freeze all their embryos or who cancel hCG administration to reduce the potential risk that high E(2) levels pose.

Extended letrozole therapy for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a novel protocol. [2009.07]
OBJECTIVE: To evaluate the outcome of long letrozole therapy for induction of ovulation in patients with clomiphene-resistant polycystic ovary syndrome (PCOS)...

Phase II randomized study of neoadjuvant everolimus plus letrozole compared with placebo plus letrozole in patients with estrogen receptor-positive breast cancer. [2009.06.01]
PURPOSE: Cross-talk between the estrogen receptor (ER) and the phosphoinositide-3-kinase (PI3K)/Akt/mammalian target of rapamycin (mTOR) pathways is a mechanism of resistance to endocrine therapy, and blockade of both pathways enhances antitumor activity in preclinical models. This study explored whether sensitivity to letrozole was enhanced with the oral mTOR inhibitor, everolimus (RAD001)... CONCLUSION: Everolimus significantly increased letrozole efficacy in neoadjuvant therapy of patients with ER-positive breast cancer.

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Clinical Trials Related to Femara (Letrozole)

Food Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2. 5 mg tablets to Novartis' Femara® 2. 5 mg tablets following a single, oral 2. 5 mg (1 x 2. 5 mg) dose administered under fed conditions.

Fasting Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2. 5 mg tablets to Novartis' Femara® 2. 5 mg tablets following a single, oral 2. 5 mg (1 x 2. 5 mg) dose administered under fasting conditions.

Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer [Terminated]
Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer. The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of atamestane, plus toremifene (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast cancer.

The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer [Terminated]
The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer, and whether the side effects of the combined hormonal therapy are different from the side effects of letrozole.

Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility [Completed]
OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group, multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited. Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles) were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S): Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Femara has an overall score of 7. The effectiveness score is 10 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
 

Femara review by 56 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   Breast Cancer
Dosage & duration:   2.5 mg. taken daily for the period of over 2.5 years (so far)
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   Since the tumor was estogen receptor positive, the treatment has resulted in any remaining canncer cells to be in remision. The side effects were mild enough that regular activities were not interfered with for the most part. It was a better alternative for me than Taxol chemotherapy which had severe side-effects for me.
Side effects:   Hastened loss of estrogen which hastened loss of sex drive (after menopause). Some temporary (fortuantely) arthritic conditions in a finger and thumb. Hastened osteoporosis. That is my bone desity decreased severely after 2 1/2 years.
Comments:   I take one tiny pill each morning with the vitamins that I take. There is no nausea or other immediate symptoms. It is simple to do.

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Page last updated: 2009-11-19

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