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Update: New drug combination for the second treatment of some HR-positive advanced breast cancers

Summary

The FDA approved Truqap plus Faslodex for the treatment of metastatic hormone receptor-positive (HR-positive), HER2-negative breast cancer that returned or worsened after treatment with hormone therapy. The approval is for treating cancers in people whose tumors had a mutation in one of three genes. For people with one of these mutations, Truqap improved the time until their cancer came back or got worse.  (Posted 2/9/24)

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New drug combination for the second treatment of some HR-positive advanced breast cancers

RELEVANCE

Most relevant for: People with hormone receptor (HR)-positive or HER2-negative breast cancer that has spread outside the breast tissue.. It may also be relevant for:

  • people with breast cancer
  • men with breast cancer
  • people with Her2-positive cancer
  • people with metastatic or advanced cancer

Relevance: Medium-High

Research Timeline: Post Approval

Relevance Rating Details


What is this update about?

Truqap (capivasertib) plus Faslodex (fulvestrant) can now be used for some people with advanced breast cancer. Faslodex is a type of hormone therapy that is given as an injection. Truqap is a pill taken by mouth; it works by stopping cancer cells from multiplying.  

The approved this combination as a second treatment in people with locally advanced or HR-positive, breast cancer in the following situations:

  • People whose breast cancer recurred and worsened after receiving hormone therapy.
  • People whose breast cancer recurred while they were on their first treatment or within 12 months of completing it.

Truqap is approved only for people with a tumor that has a mutation in one of three genes: PIK3CA, ATK1 or . The Foundation One CDx tumor test was also approved by the for use in identifying people who are most likely to benefit from this new combination treatment. 

Study findings

The approval was based on the CAPItello-291 study, which compared Truqap plus Faslodex to Faslodex alone. Just over 700 people with locally advanced or HR-positive, breast cancer participated in this trial. One group received Truqap plus Faslodex, while the other group received Faslodex alone.

Researchers looked at the time until cancer returned in both groups.

Among all participants:

  • Cancer did not return for about 7 months in the group that received Truqap plus Faslodex compared to about 4 months in the group that received Faslodex alone.

When researchers looked at the subset of participants with a tumor mutation in PIK3CA, ATK1 or PTEN:

  • Cancer did not return for just over 7 months in the group that received Truqap plus Faslodex compared to 3 months in the group that received Faslodex alone.

At 18 months, overall survival was higher in the group that received Truqap plus Faslodex compared to the group that received Faslodex alone. 

Truqap side effects

Truqap side effects included:

  • Rash
  • Diarrhea
  • High blood sugar
  • Hyperglycemia (need insulin and hospitalization)

Among patients who received Truqap, rash and diarrhea were the most common side effects reported. Hyperglycemia (high blood sugar) occurred in 18 percent of these patients.  Grade 3 hyperglycemia (need insulin and hospitalization) or Grade 4 (life-threatening) occurred in 2.8 percent of patients.

Fasting blood glucose and hemoglobin A1C levels should be checked for normal levels before taking Truqap. People taking Truqap who have a medical history of diabetes should be monitored more frequently.

What does this mean for me?

If you have or locally advanced or breast cancer that recurs after your first treatment, ask your healthcare provider about testing your tumor to see if you may be eligible for Truqap plus Faslodex or another targeted treatment.

The new drug combination may increase the time until your cancer comes back, especially if your tumor has a mutation in a PIK3CA, ATK1 or gene. It may also help to maintain your quality of life and delay time until chemotherapy is needed.

Reference

approves capivasertib with fulvestrant for breast cancer. news release. November 16, 2023.

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

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posted 2/9/24

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • Have I had tumor testing?
  • Is Truqap right for me?
  • If I am diabetic, can I take Truqap?
  • Where can I get a blood sugar test? How often do I need to retest while taking Truqap?
  • Are there any other medications I can take if I can’t take Truqap?

Guidelines
Guidelines

The National Comprehensive Cancer Network (NCCN) indicates that tumor testing can help determine if a person with breast cancer would benefit from .

  • For tumors that are hormone receptor-positive, , testing for PIK3CA, ATK1 or mutations is recommended to help identify patients who would benefit from a known as a PI3K inhibitor.
  • For tumors that are hormone receptor-negative, , testing for is recommended to help identify patients who might benefit from .
  • For  breast tumor types, testing for MSI-H/dMMR or other biomarkers may help identify patients who would benefit from

Updated: 01/29/2024

Open clinical trials
Open clinical trials

The following are studies looking at treatment for people with HER2-positive breast cancer.  

Other clinical trials for people with breast cancer can be found here.

Updated: 07/21/2022

Peer Support
Peer Support

The following organizations offer peer support services for people with, or at high risk for breast cancer:

Updated: 11/29/2022

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