Being treated for cancer can be a frightening and confusing time, for you as the patient and for your family, friends, and loved ones.
Joining a clinical study may be a good option for you. Talk to your doctor about your choices and the risks and benefits of each choice.
Watch this video to learn more about clinical trials, how they work, and how they could advance research for your condition.
What is the evERA Breast Cancer Study?
The study will compare the effects, good or bad, of two different investigational combinations of anticancer medicines for ER-positive/HER2-negative breast cancer that has spread to parts of the body beyond the breast. This spreading of the disease may be called “locally advanced” or “metastatic” and means the cancer has returned or worsened after previous treatment.
Your doctor can best answer any questions about the evERA Breast Cancer Study and help you understand the study and if it makes sense for you.
Who can be in the study?
You may be able to join the study if:
- You have been previously treated for breast cancer, AND
- The cancer has returned or worsened, AND
- The cancer cells have spread in a way that cannot be treated with surgery, AND
- The cancer cells are estrogen receptor (ER)-positive/human epidermal growth factor (HER2)-negative.
How long is the study?
The total time in the study depends on many factors, including how/if your cancer responds to study treatment.
Your time in the study could range from 1 day to 36 months or more.
What happens
during the study?
The study has 3 parts: Screening, Study Treatment, and Follow-Up.
You will visit the study clinic twice a month for the first 2 months, then approximately once every month while you are receiving study treatment.
Visits may last 1-6 hours.
Screening
to see if you qualify for the study.
Study Treatment
which is given in cycles of 28 days. You will continue to take the study treatment on a regular basis unless your cancer worsens, you have unacceptable side effects, or you decide not to continue in this study.
Follow-Up
to check on you after study treatment is finished.
What is the study treatment?
There are 2 treatment groups. Your treatment group will be decided by chance (like tossing a coin). You will have an equal chance of being placed in either group. This is an open-label study, which means that you and your study doctor will know which group you are placed in.
Group 1
Giredestrant
+
Everolimus (AFINITOR®)
or
Group 2
Your study doctor’s choice of endocrine therapy*
+
Everolimus (AFINITOR®)
*Your study doctor will choose for you to receive one of the following endocrine therapies: exemestane (AROMASIN®), fulvestrant (FASLODEX®), or tamoxifen.
Giredestrant, everolimus, exemestane, and tamoxifen come as oral pills that are taken once a day. Fulvestrant is given
as an intramuscular injection – twice a month for the first month only, and then monthly thereafter.
There is no placebo in this trial. Everyone receives treatment with breast cancer medications.
You will also be asked to take other medicines during the study.
What tests will I have?
At study visits, you will answer questions about your health, any medicines you are taking, and any side effects that you may experience.
You will have health checks and tests such as:
Vital Signs
Physical Exam
Biopsy (if needed)
Tumor Scans
Head Scan (if needed)
Bone Scan
Heart Test
Blood Tests
Urine Test
Pregnancy Test (if applicable)
Questionnaires
How do I find a study clinic?
Enter your zip code to find a study site near you, and call 888-662-6728 (US only) or visit this site (all countries) to talk to our team about joining the study.
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More About the Study Treatments
Giredestrant blocks cancer cells from being able to receive estrogen’s signal to grow and multiply.
Giredestrant has had limited testing in humans. So far, the known side effects of this drug appear to be mild to moderate in severity with no known serious risks. The vast majority of these side effects resolved without the need for treatment or interruption of giredestrant.
Side effects that have happened in more than 10 out of 100 patients treated with giredestrant include: joint pain (arthralgia), diarrhea, high levels of certain liver enzymes, which may indicate possible liver damage (aspartate aminotransferase increased/alanine aminotransferase increased), fatigue, muscle and/or bone pain, and nausea.
Side effects that have happened in 1 – 10 out of 100 patients treated with giredestrant include: hot flashes, slow heartbeat (bradycardia), headache, vomiting, and dizziness.
The potential side effects listed below are not confirmed to be caused by giredestrant but it is anticipated that they may occur on the basis of human and laboratory studies or reported from drugs similar to giredestrant. Also, there may be side effects that are not anticipated at this time.
Potential side effects include: blood clots, kidney damage, changes to female reproductive organs, including fluid-filled lump in the ovary (ovarian cysts) and decreased uterine weight, infertility, menopausal symptoms (because giredestrant blocks the action of female sex hormones, its effects are similar to, but potentially more severe than, those of normal menopause such as loss of muscle and bone, vaginal dryness or discharge, irritation, mood swings, and decreased interest in sex), possible harm to a developing fetus, including birth defects and miscarriage.
Exemestane decreases the amount of estrogen your body makes.
Important side effects associated with exemestane are listed below. Your study doctor will provide information about these and other side effects. There may be side effects that are not known at this time.
Side effects that have happened in more than 1 out of 10 patients treated with exemestane include: sleep disorder (insomnia), headache, hot flashes, nausea, decreased white blood cell counts (leukopenia), hepatic enzyme increased, blood alkaline phosphatase increased, increased sweating, joint, muscle and/or bone pain (joint and musculoskeletal pain), fatigue, depression, dizziness, blood bilirubin increased, abdominal pain, pain.
Side effects that have happened in up to 1 out of 10 patients treated with exemestane include: loss of appetite (anorexia), numbness, tingling and weakness in the hand and arm (carpal tunnel syndrome), tingling or numbness in the hand, arms, legs, or feet (paresthesia), vomiting, decreased platelet counts (thrombocytopenia), constipation, heartburn (dyspepsia), diarrhea, rash, hair loss (alopecia), hives (urticaria), itching (pruritus), bone thinning (osteoporosis), broken bone (fracture), and swelling in lower legs and hands (edema peripheral).
Side effects that are less common but important and have happened in less than 1 out of 100 patients include: hypersensitivity, sleepiness, state of feeling drowsy, ready to fall asleep (somnolence), inflammation of the liver (hepatitis), severe skin reaction to drugs (acute generalized exanthematous pustulosis), weakness (asthenia), and liver disease that causes inflammation of the liver (cholestatic hepatitis).
Additional risks of exemestane include:
- If you or your partner get pregnant, use of exemestane may negatively affect your unborn child (embryofetal toxicity)
- Decrease in one type of white blood cells (lymphoctopenia) (frequency unknown)
Learn more about exemestane here.
Everolimus stops cancer cells from reproducing, decreases the blood supply to the cancer cells, and starves cancer cells from taking up glucose (blood sugar) for energy.
Side effects that have happened in more than 1 out of 10 patients treated with everolimus include: mouth sores (stomatitis), rash, feeling weak or tired (fatigue), diarrhea, infections, which may be serious, nausea, decreased appetite, decreased red blood cells counts (anemia), change in taste (dysgeusia), inflammation in lung (pneumonitis), swelling in lower legs and hands (edema peripheral), high blood sugar (hyperglycemia), weakness (asthenia), itching (pruritus), weight decreased, high cholesterol (hypercholesterolemia), nose bleeds (epistaxis), cough, and headache.
Side effects that have happened in up to 1 out of 10 patients treated with everolimus include: decreased platelet counts (thrombocytopenia), decreased white blood cells counts (leukopenia), decreased certain types of white blood cells counts (neutropenia and lymphopenia), high blood triglyceride level (hypertriglyceridemia), low level of phosphate (hypophosphatemia), diabetes mellitus, elevated fat levels (hyperlipidemia), low blood potassium (hypokalemia), loss of water (dehydration), low blood calcium (hypocalcemia), sleep disorder (insomnia), joint pain (arthralgia), protein in the urine (Proteinuria), blood creatinine increased, renal failure, menstruation irregular, fever (pyrexia), shortness of breath (dyspnea), vomiting, dry mouth, abdominal pain, mucosal inflammation, oral pain, indigestion (dyspepsia), difficulty in swallowing (dysphagia), high levels of certain liver enzymes, which may indicate possible liver damage (aspartate aminotransferase increased/alanine aminotransferase increased), dry skin, nail disorders, mild hair loss (mild alopecia), acne, redness of skin (erythema), breaking of the nail (onychoclasis), swelling, numbness, tingling, or redness of the hands or feet (palmar-plantar erythrodysesthesia syndrome), skin exfoliation, skin lesion, eyelid edema, bleeding (hemorrhage), high blood pressure (hypertension), swelling and/or discomfort of part or all of your arms and legs (lymphedema).
Side effects that are less common but important and have happened in less than 1 out of 100 patients include: decreased all three types of blood cells counts (pancytopenia), hypersensitivity (which may be severe), pink eye (conjunctivitis), heart failure (congestive cardiac failure), flushing, clot in a deep vein (deep vein thrombosis), coughing up blood (hemoptysis), blockage in the lung artery (pulmonary embolism), increased daytime urination, acute renal failure, absence of menstruation (amenorrhea), non-cardiac chest pain, impaired wound healing, a type of anemia affecting the precursors to red blood cells (pure red cell aplasia), sudden and serious lung failure (acute respiratory distress syndrome), swelling of the lower layer of skin and tissue (angioedema), and loss of taste (ageusia).
Other side effects known to be associated with everolimus include: inflammation (swelling and redness) of the skin caused by drugs after radiation therapy (radiation recall syndrome) and increasing (potentiation) of reaction to radiation.
Additional risks of everolimus include:
- If you receive radiation, everolimus may increase the cell damage caused by irradiation (radiation sensitization)
- Infection or reduced immune response with vaccination, the vaccine may not work as well which means you may still get an infection after being vaccinated
- If you or your partner get pregnant, use of everolimus may negatively affect your unborn child (embryofetal toxicity)
- You may be more likely to develop active hepatitis B if you have had hepatitis B in the past (reactivation)
Learn more about everolimus here.
Fulvestrant blocks cancer cells from being able to receive estrogen’s signal to grow and multiply.
Important side effects associated with fulvestrant are listed below. Your doctor will provide information about these and other side effects. There may be side effects that are not known at this time.
You may need immediate medical treatment if you experience any of the following side effects: allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue, and/or throat that may be signs of anaphylactic reactions; thromboembolism (increased risk of blood clots); inflammation of the liver (hepatitis); or liver failure.
Side effects that have happened in more than 1 out of 10 patients treated with fulvestrant include: injection site reactions, such as pain and/or inflammation; abnormal levels of liver enzymes (in blood tests); nausea (feeling sick); weakness, tiredness; joint and musculoskeletal pain; hot flashes; skin rash; and allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat.
Side effects that have happened in up to 1 out of 10 patients treated with fulvestrant include: headache; vomiting, diarrhea, or loss of appetite; urinary tract infections; back pain; increase of bilirubin (bile pigment produced by the liver); thromboembolism (increased risk of blood clots); decreased levels of platelets (thrombocytopenia); vaginal bleeding; lower back pain irradiating to the leg on one side (sciatica); and sudden weakness, numbness, tingling, or loss of movement in your leg, especially if only on one side of your body, sudden problems with walking or balance (peripheral neuropathy).
Side effects that have happened in up to 1 out of 100 patients treated with fulvestrant include: thick, whitish vaginal discharge and candidiasis (infection); bruising and bleeding at the site of injection; increase of gamma-GT, a liver enzyme seen in a blood test; inflammation of the liver (hepatitis); liver failure; numbness, tingling and pain; and anaphylactic reactions.
Learn more about fulvestrant here.
Tamoxifen blocks cancer cells from being able to receive estrogen’s signal to grow and multiply.
Important side effects associated with tamoxifen are listed below. Your doctor will provide information about these and other side effects. There may be side effects that are not known at this time.
Stop taking tamoxifen and seek medical advice immediately if you develop the following symptoms: allergic reactions: swelling of the face, throat or tongue, fever; difficulty in breathing, dizziness; swelling of the face, lips, tongue or throat; difficulty in swallowing or breathing (angioedema); tamoxifen may cause or worsen symptoms of hereditary angioedema; symptoms of a blood clot: swelling of the calf or leg, chest pain, being short of breath or suddenly feeling weak; symptoms of a stroke: sudden onset of the following: weakness or paralysis of the arms or legs, being unable to move the arms or legs, sudden difficulty speaking, walking, or holding things, or difficulty thinking; fever, general ill feeling, itching, joint aches, multiple skin lesions (erythema multiforme); blistering of the skin (bullous pemphigoid); reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens−Johnson syndrome; toxic epidermal necrolysis) – these side effects occur rarely.
Seek medical advice immediately if you notice any of the following symptoms: unusual bleeding or a discharge from your vagina; irregular periods, especially if associated with heavier bleeding; or a feeling of discomfort, pain or pressure in the lower tummy (pelvis).
Side effects that have happened in more than 1 out of 10 patients treated with tamoxifen include: tiredness, weakness, or lack of energy (fatigue); feeling sick (nausea); fluid retention; skin rashes; hot flushes; and depression.
Side effects that have happened in up to 1 out of 10 patients treated with tamoxifen include: damage to the retina [light-sensitive tissue lining the back of the eye] (retinopathy); tingling or numbness in the hand or feet (paraesthesia); abnormal sense of taste (dysgeusia); increase in risk of blood clots; leg cramp; muscle pain (myalgia); increased level of fats (triglycerides) in the blood (detected by blood tests); looking pale and feeling tired (anemia); cloudy patches in the lens of the eye, causing blurred vision (cataracts); changes in the womb (including changes to the lining and benign growths); headache; feeling lightheaded; itching of the area around the vagina [vulva] (pruritus vulvae); hair loss (alopecia); being sick (vomiting); diarrhea; constipation; changes in liver enzyme levels (detected by blood tests); build-up of excess fats in the liver (fatty liver).
Side effects that have happened in up to 1 out of 100 patients treated with tamoxifen include: if you have bone cancer (bony metastases) you may develop high levels of calcium in the blood (hypercalcaemia) on starting treatment with tamoxifen; inflammation of the lungs (interstitial pneumonitis); increased risk of womb (uterus) cancer (endometrial cancer); a reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia); a reduction in white blood cells (leucopenia); visual disturbances; inflammation of the pancreas (pancreatitis); and scarring of the liver as a result of continuous, long-term liver damage (cirrhosis).
Side effects that have happened in up to 1 in 1000 patients treated with tamoxifen include: changes to the cornea (the clear, dome-shaped, window covering the front of the eye); a reduction in white blood cells (neutropenia); increased risk of cancer of the muscle and supporting tissues of the womb [uterus] (uterine sarcoma); inflammation of the optic nerve causing blurring, blind spots, distorted vision, reduced color vision, and pain when moving the eyes. In a small number of cases blindness may occur (optic neuropathy/optic neuritis); increase in the size of tumors (tumor flare); inflammation of the liver (hepatitis); build-up of bile acids in the bloodstream causing persistent itch (cholestasis); liver failure or damage (hepatocellular injury/hepatic necrosis); inflammation of the blood vessels in the skin causing a rash (cutaneous vasculitis); condition where small pieces of the womb lining are found outside the womb causing symptoms such as painful periods, persistent pain in the pelvic area, and infertility (endometriosis); swelling of ovarian cysts (growth on, or inside, the ovary); small, soft growths (polyps) on the vagina; and being more prone to infections due to a severe reduction in number of white blood cells (agranulocytosis).
Side effects that have happened in up to 1 in 10,000 patients treated with tamoxifen include: condition which causes joint pain, skin rashes, and fever (Cutaneous Lupus Erythematosus [CLE]); sensitivity of the skin to sunlight (Porphyria Cutanea Tarda [PCT]); and radiation recall – skin rash involving redness, swelling, and/or blistering (like severe sunburn) of the skin after receiving radiation therapy.
Learn more about tamoxifen here.
Resources
Learn more about the evERA Breast Cancer Study and clinical trials:
For Patients with Breast Cancer
Learn more about your condition and what's involved in participating in a clinical trial.
For Patients' Loved Ones & Community
As a person supporting someone with breast cancer, you may find these resources helpful.
