Truqap (capivasertib) is a targeted therapy for breast cancer. Unlike chemotherapy, which can harm both healthy and cancer cells, targeted therapy aims at specific proteins in the cancer cells that drive them to grow more quickly than normal. The FDA approved Truqap in 2023 to treat advanced breast cancer that is positive for hormones (HR-positive) in people who have changes in certain genes and whose cancer has gotten worse during or after taking hormonal cancer medicines. Truqap is taken together with a hormone therapy medicine called fulvestrant.
How Does Truqap Work in HR-Positive Breast Cancer?
Some people with HR-positive breast cancer also have changes in certain genes called PIK3CA, AKT1, or PTEN. When there is a change in the AKT1 gene, cancer cells can grow and multiply faster. Truqap helps slow down this growth by stopping AKT from working.
In addition, HR-positive breast cancer cells depend on hormones such as estrogen in the blood to grow. That is why you need to take Truqap with fulvestrant. While Truqap works to stop AKT, fulvestrant blocks estrogen from reaching cancer cells. Together, they target both parts of cancer growth.
Is Truqap Right for Me?
Truqap may be the right choice for you if:
- Your cancer is advanced or has spread to other parts of your body (metastatic).
- You have certain gene changes confirmed by specific tests.
- Your cancer has grown while or after you’ve taken cancer hormonal medicines, or it has come back within a year of other cancer treatments.
Your doctor will test your cancer for gene changes and review your medical history to decide if Truqap is right for you.
How Was Truqap Studied for Treating HR-Positive Breast Cancer?
One clinical study was done to look at the benefits and risks of Truqap taken in combination with fulvestrant in people with HR-positive breast cancer and AKT gene changes.
The main question this study wanted to answer was: How well does Truqap work in people who took Truqap plus fulvestrant, compared to those who took fulvestrant alone?
To learn this, the researchers measured how long it took for the people in the study to experience worsening of cancer. This is called “progression-free survival” and shows how well a medicine controls a disease.
Researchers also measured how long the people in the study lived in general. This is called “overall survival” and shows how much the medicine helps the people in the study live longer.
Researchers also looked at the general health status and quality of life of the people in the study.
What medicines did the people in the study take?
Half of the people in the study got Truqap plus fulvestrant, and the other half got fulvestrant alone. Neither the people in the study nor the doctors knew who received which medicines. People continued to be in the study until their cancer got worse or they had unacceptable side effects.
Who was included in the study?
To take part in the study, people had to:
- Be at least 18 years of age (adult)
- Have advanced breast cancer that could not be treated with surgery
- Have advanced breast cancer that had gotten worse or returned during or after treatment with cancer hormonal therapy
- Have previously taken a maximum of two series of different hormonal therapies
- Have received a maximum of one type of chemotherapy
Who was excluded from the study?
People could not be in this study if they:
- Had other diseases that could get worse with the study treatments
- Had been treated with medicines similar to those given in the study
- Had chemotherapy within 3 weeks and radiotherapy within 4 weeks before the study
- Had taken certain medicines and natural supplements that could affect the study medicines
- Had diabetes and gotten insulin or had very high blood sugar levels
- Had certain blood clotting problems or were taking blood thinners that did not allow the injection of fulvestrant
- Were pregnant or breastfeeding
What was the study population?
- A total of 708 people were in this study.
- About 41% of them had changes in their PIK3CA, AKT1, or PTEN genes.
- Among this group, the age ranged from 34 to 90 years.
- Almost all (99%) were women.
- About 52% were White, 29% were Asian, 1% were Black, 0.7% were American Indian/Alaska Native, 17% were from other racial backgrounds, and 9% identified as Hispanic/Latino.
What Were the Main Benefits of Truqap Plus Fulvestrant Seen in the Study?
The main benefits seen within the group who had changes in their PIK3CA, AKT1, or PTEN genes were:
Progression-free survival: People who got Truqap plus fulvestrant lived significantly longer before their cancer worsened, compared to those who got fulvestrant alone.
Overall survival: At 18 months after getting the medicines, about 73% of the people who got Truqap plus fulvestrant were alive, compared to about 63% of those who only got fulvestrant.
Quality of life: People who got Truqap plus fulvestrant maintained their general health status and quality of life for a longer period of time, compared to those who got fulvestrant alone.
What Are the Possible Side Effects of Truqap, and How Can I Prevent or Manage Them?
Truqap can cause severe side effects, including high blood sugar levels, diarrhea, and skin reactions.
Contact your health care provider right away if you notice any new rash or an existing rash that is getting worse; reddening of the skin; a fever; blistering of the lips, eyes or mouth; blisters on the skin; skin peeling; or dry skin. They will decide whether you should continue, adjust the dose, or stop taking Truqap. They will also recommend creams or antihistamines to help with your rash and itchiness. Skin reactions can happen at any time during treatment with Truqap.
Notify your health care provider as soon as diarrhea starts, and take diarrhea medicines. Drink more fluids to avoid losing too much of your body water (dehydration). Mild to moderate diarrhea is the most common side effect of Truqap and can happen any time after you start taking it. Your pharmacist can help you choose the right medicine for diarrhea.
Monitor your fasting blood sugar levels (blood sugar after an overnight fast) regularly while you are taking Truqap. Contact your health care provider if you notice your blood sugar rising or start having symptoms like feeling unusually thirsty, needing to pee more often or in greater amounts, and eating more but losing weight. Your health care provider will have you get lab tests regularly and decide how to best manage your blood sugar levels. Based on the results, they will decide whether you should continue, adjust the dose, or stop taking Truqap.
Other common side effects of Truqap are nausea, tiredness, vomiting, mouth sores, and changes in certain blood tests.
Do not stop taking Truqap or change your dose unless your health care provider tells you to do so.
These are not all the possible side effects of Truqap. Contact your health care provider for medical advice about side effects if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
How Do I Know if Truqap Is Working?
Your health care provider will regularly check how well Truqap is working for your cancer by looking at results of tests such as blood tests and CT scans, MRI scans, and bone scans. Take Truqap exactly as your health care provider tells you. Do not change your dose or stop taking Truqap unless your health care provider tells you to.
How Do Other Medicines or Foods Interact With Truqap?
Inform your health care provider and pharmacist about all the other prescription and over-the-counter medicines, vitamins, supplements, and herbal products you take. Some medicines and foods may interfere with how Truqap works in your body. Similarly, Truqap can affect other medicines.
This is because some foods and medicines can interfere with one of the proteins that help break down Truqap before it leaves your body, called CYP3A.
Foods or medicines that can stop CYP3A from working are called CYP3A inhibitors, while those that can make it more active are called CYP3A inducers.
CYP3A inhibitors make Truqap linger in your body longer than it should, causing more side effects. Some medicines in this group include certain antibiotics (like erythromycin), antifungals (like itraconazole), and heart medicines (like verapamil).
Do not eat grapefruit or its juice while you are taking Truqap.
CYP3A inducers cause Truqap to leave your body quicker, making it less effective. Some examples of these medicines are certain antibiotics (like rifampicin) and HIV medicines (like efavirenz).
Truqap, in turn, may increase the levels of some other medicines in the blood, causing side effects of those medicines. Examples of these medicines are midazolam (a medicine that treats anxiety, tension, nausea, and vomiting), and desipramine (a medicine that treats depression).
Your health care provider will decide if you need to stop taking a medicine or avoid certain foods while you are taking Truqap, or if you need to adjust your dose of Truqap. Your pharmacist can tell you which foods or medicines interact with it.
These are not all the possible interactions with Truqap. Consult with your health care provider before taking any other prescription and over-the-counter medicines, vitamins, supplements, and herbal products while you are taking Truqap.
How Can I Get Truqap?
You will need a prescription from a health care provider who has experience in the use of medicines for cancer (oncologist). Your oncologist will arrange for you to get Truqap, which is only available at specialty pharmacies.
If you need support to pay for Truqap, the drugmaker may be able to help you. You can go to https://www.myaccess360.com to learn more about their patient assistance program. You can also contact the drugmaker at 844-ASK-A360 (844-275-2360).
