Faslodex (fulvestrant) is a prescription medicine used for people with certain types of breast cancer.
Faslodex is given as an injection into the buttocks (gluteal area) by a health care provider in a health care setting. It may be given alone or as part of a treatment regimen with other chemotherapy medicines.
How Does Faslodex Work for Breast Cancer?
Estrogen is a natural hormone in your body. Many breast cancers have estrogen receptors, which bind to estrogen. When estrogen attaches to the estrogen receptor on breast cancer cells, it helps the breast cancer cells grow or multiply.
Faslodex is a type of medicine known as hormone therapy. Like estrogen, it can also bind to the estrogen receptor. When it does, it prevents the body’s estrogen from binding to it. But unlike estrogen, when Faslodex binds to the receptor, it does not help the cancer grow more. Faslodex also lowers the activity of the estrogen receptor, which prevents even more estrogen from binding to the cancer cells.
Is Faslodex Right for Me?
Faslodex may be the right choice for you if any of the following apply.
- You have hormone-receptor-positive (HR-positive) breast cancer
- Your cancer has grown while you were on or after you took at least one other cancer hormonal medicine
- You have not used other hormonal medicine, but your cancer is advanced
- Your cancer has spread to other areas
How Was Faslodex Studied for Breast Cancer?
Faslodex was studied in the following ways.
- As monotherapy, meaning it was the only medicine used in the breast cancer treatment regimen
- As part of combination therapy, meaning it was used in combination with other cancer medicines
Monotherapy
CONFIRM Trial
The CONFIRM trial was done to compare the 500 mg dose of Faslodex to the 250 mg dose in women who had gone through menopause and had estrogen-receptor-positive advanced breast cancer. These women also had their cancer get worse after at least one other hormonal medicine.
There were a total of 736 women in the CONFIRM trial. The median (which is the middle-most value) age of people in this trial was 61. The race or ethnicity of the people in the trial was not reported.
To see if Faslodex worked, researchers looked at the progression free survival (PFS). PFS is the amount of time that a person lives with the disease, without the disease getting worse. The people in the 500 mg Faslodex group had a median PFS of 6.5 months. People in the 250 mg Faslodex group had a median PFS of 5.5 months. This is about 20% reduction in the risk of progression. At 12 months, about 34% of the people in the 500 mg Faslodex group had PFS, compared to only 25% in the Faslodex 250 mg group.
FALCON Trial
The FALCON trial was done to compare Faslodex 500 mg to another medicine for breast cancer, called anastrozole 1 mg, in people who had gone through menopause and had estrogen-receptor-positive and/or progesterone-receptor-positive, human epidermal growth factor receptor 2-negative (HER2-negative) advanced breast cancer or metastatic breast cancer. Metastatic cancer means it has spread to other parts of the body. People in this study had not been treated with hormone medicine for their breast cancer in the past.
People received either Faslodex or anastrozole. The people in the Faslodex group got Faslodex 500 mg as an injection into the muscle on days 0, 14, and 28 of the first cycle and then every month after that. The people in the anastrozole group took a 1 mg oral tablet every day.
There were a total of 462 people in the FALCON trial. The median age of people in this trial was 63. About 87% of the people in this trial had breast cancer that was metastatic. About 76% were White, 15% were Asian, and 9% were Black or of other races. Most people (about 75%) had breast cancer that was estrogen-receptor- and progesterone-receptor- positive.
To compare how the two medicines worked, researchers looked at the PFS. The people in the Faslodex group had a longer PFS than those in the anastrozole group. Specifically, people in the Faslodex group had a median PFS of 16.6 months, and people in the anastrozole group had a median PFS of 13.8 months.
A table summarizing the results of the monotherapy trials is included below.
| Trial | Patient Characteristics | Breast Cancer Type | PFS |
|---|---|---|---|
CONFIRM
| Median age: 61
Postmenopausal
Race unknown | Estrogen-receptor-positive advanced breast cancer that got worse after hormonal medicine
| Faslodex 500 mg: 6.5 months Faslodex 250 mg: 5.5 months |
FALCON
| Median age: 63
Postmenopausal
Race: 76% White, 15% Asian, 9% Black or other | HR-positive, HER2-negative advanced or metastatic breast cancer
| Faslodex 500 mg: 16.6 months
13.8 months
|
Combination Therapy
Faslodex has been studied in combination with other cancer medicines, including palbociclib (Ibrance), abemaciclib (Verzenio), and ribociclib (Kisqali).
Faslodex plus palbociclib (PALOMA-3)
The PALOMA-3 trial studied how well Faslodex worked when used in combination with palbociclib in 521 women with HR-positive, HER2-negative breast cancer that had gotten worse on previous hormone therapy. Women received either Faslodex plus palbociclib or Faslodex plus a placebo. Faslodex was given as an injection into the muscle, and palbociclib was given as an oral capsule. The placebo did not contain any active medicine.
People in this study had a median age of 57. About 74% were White, 20% Asian, and 6% Black or of other races. About 79% were postmenopausal.
To compare how the medicines worked, researchers looked at the PFS. Adding palbociclib to Faslodex led to a better improvement in PFS. Specifically, the median PFS was 9.5 months in the Faslodex plus palbociclib group and 4.6 months in the Faslodex plus placebo group.
Faslodex plus abemaciclib (MONARCH-2)
The MONARCH-2 trial studied how well Faslodex worked when used in combination with abemaciclib in 669 women with HR-positive, HER2-negative breast cancer that had gotten worse on previous hormone therapy and spread to other sites of the body.
Women received either Faslodex plus abemaciclib or Faslodex plus a placebo. Women who had not yet reached menopause received another medicine called goserelin before and during treatment. Faslodex was given as an injection into the muscle, and abemaciclib was given as an oral tablet. The placebo did not contain any active medicine.
People in this study had a median age of 60. About 56% were White, 20% Asian, and 6% Black or of other races. About 83% had already gone through menopause.
To compare how the medicines worked, researchers looked at the PFS. The study showed that adding abemaciclib to Faslodex led to an improvement in PFS. Specifically, people who received Faslodex plus abemaciclib had a median PFS of 16.4 months, and those who received Faslodex alone had a median PFS of 9.3 months.
Faslodex plus ribociclib (MONALEESA-3)
The MONALEESA-3 trial studied how well Faslodex worked when used in combination with ribociclib in 726 women who had gone through menopause (postmenopausal) and had HR-positive, HER2-negative breast cancer. People in this trial either had not received hormone treatment before, or they had and their breast cancer had gotten worse.
Women received either Faslodex plus ribociclib or Faslodex plus a placebo. Faslodex was given as an injection into the muscle, and ribociclib was given as an oral tablet. The placebo did not contain any active medicine.
People in this study had a median age of 63. About 85% were White, 9% Asian, and 0.7% Black or of other races.
To compare how the medicines worked, researchers looked at the PFS. The study showed that adding ribociclib to Faslodex led to an improvement in PFS. Specifically, people who received Faslodex plus ribociclib had a median PFS of 20.5 months, and those who received Faslodex alone had a median PFS of 12.8 months.
A table summarizing the results of the combination trials is included below.
| Trial | Patient Characteristics | Breast Cancer Type | PFS |
|---|---|---|---|
PALOMA-3
| Median age: 57
All women, regardless of menopause status
Race: 74% White, 20% Asian, 6% Black or other
| HR-positive, HER2-negative advanced breast cancer that got worse after hormonal medicine
| Faslodex plus palbociclib: 9.5 months Faslodex plus placebo: 4.6 months
|
MONARCH-2
| Median age: 60
All women, regardless of menopause status
Race: 56% White, 32% Asian, 6% other, 6% not reported
| HR-positive, HER2-negative, metastatic breast cancer that got worse after hormonal medicine
| Faslodex plus abemaciclib: 16.4 months Faslodex plus placebo: 9.3 months
|
MONALEESA-3
| Median age: 63
Postmenopausal
Race: 85.5% White, 9% Asian, 0.7% Black, 0.8% Native American, 2% other, 2% unknown
| HR-positive, HER2-negative, advanced breast cancer that got worse after hormonal medicine or had never had it
| Faslodex plus ribociclib: 20.5 months Faslodex plus placebo: 12.8 months
|
Your results may differ from what was seen in clinical studies.
How Often Will I Receive Faslodex?
The dose, schedule, and duration of Faslodex that you will receive shall depend on the type of cancer that you have. Most people will get Faslodex on days 1, 15, and 29 of their first chemotherapy cycle and then once a month after that. You may receive other medicines for your breast cancer in addition to Faslodex, or you may receive Faslodex alone. Follow all instructions from your health care provider on when to return for your next injection.
How Do I Know if Faslodex Is Working?
You may not see changes right away. It may take weeks to months before your health care provider can tell if Faslodex is working for you. Your health care provider will look at your blood tests, scans, and symptoms to know if your breast cancer is progressing.
What Are the Possible Side Effects of Faslodex, and How Can I Prevent Them?
Common side effects of Faslodex and management tips are included in the table below.
Common Side Effect | Management Tips |
|---|---|
| Injection site reactions (redness, swelling, pain, or itching where the shot was given) | Apply a cold pack for 10-15 minutes. Wear loose clothing. Let your health care provider know if pain lasts more than a few days. |
| Nausea, vomiting, or loss of appetite | Eat smaller meals with bland food. Sip clear fluids. Let your health care provider know if these symptoms are severe or they do not go away. |
| Headache, bone, joint, muscle, or back pain | You can try warm compresses, stretching, or over-the-counter pain medicines, such as acetaminophen or ibuprofen, if your health care provider approves. |
| Tiredness or weakness | Rest often throughout the day. Avoid heavy exertion. Pace your activities to avoid overexertion. |
| Hot flashes | Dress in layers. Avoid spicy foods and caffeine. |
| Constipation | Drink lots of water, and eat fiber-rich foods such as vegetables and whole grains. |
Is There Any Cost Assistance Available for Faslodex?
There may be cost assistance to help you afford Faslodex. You may have options even if you do not have health insurance. Your health care provider can help you get started, or you can call Access 360 at 844-ASK-A360 (844-275-2360), Monday through Friday, 8 AM to 6 PM EST, excluding holidays, or email them at [email protected].
