Update: FDA approves tucatinib (Tukysa) for metastatic Her2-positive breast cancer
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The FDA has approved the use of tucatinib (Tukysa) in combination with chemotherapy as a treatment for people with metastatic Her2-positive breast cancer. This approval includes treatment of people whose breast cancer has spread to the brain. (4/29/20)
Summary
The FDA has approved the use of tucatinib (Tukysa) in combination with chemotherapy as a treatment for people with metastatic Her2-positive breast cancer. This approval includes treatment of people whose breast cancer has spread to the brain. (4/29/20)
Relevance
This article is most relevant for Patients with Her2-positive metastatic breast cancer
Relevance: High
Research Timeline: Post Approval
Contents
| At a glance | Guidelines |
| Findings | Questions for your doctor |
| Clinical trials | Resources |
APPROVAL AT A GLANCE
This report is about:
approval of the drug tucatinib (Tukysa) in combination with chemotherapy for treating Her2-positive breast cancer.
Why is this approval important?
Recurrent Her2-positive breast cancer is an aggressive type of cancer with limited options, especially for people whose disease has spread to the brain. On April 17, 2020, the U.S. Food and Drug Administration () granted approval of Tukysa in combination with chemotherapy for the treatment of advanced, breast cancer in people who have received at least one prior therapy for disease.
Research findings:
approval of Tukysa in combination with chemotherapy was based on previous research, which we reported in this XRAY review. The HER2CLIMB study looked at 612 patients with Her2-positive breast cancer. For participants who received Tukysa plus chemotherapy:
- at 1 year, the risk of disease progression or death was 46 percent lower compared to the group.
- at 1 year, the risk of disease progression or death was 52 percent lower among participants with brain metastases compared to those in the group.
- at 2 years, the risk of death was 34 percent lower.
- almost twice as many participants experienced a reduction in the size or a disappearance of their cancer compared to the group.
Most adverse events that occurred were not severe, but included:
- diarrhea
- hand-foot syndrome
- nausea
- fatigue
- vomiting
The warns that Tukysa can cause serious side effects, including severe diarrhea associated with dehydration, acute kidney and liver damage.
What does this mean for me?
If you have been diagnosed with locally advanced or breast cancer, you may want to talk to your doctor about whether Tukysa is right for you.
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Reference:
Approves First New Drug Under International Collaboration, A Treatment Option for Patients with Metastatic Breast Cancer. Website. April, 2020.
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.
This article is relevant for:
Patients with Her2-positive metastatic breast cancer
This article is also relevant for:
people with breast cancer
people with Her2-positive cancer
men with breast cancer
people with metastatic or advanced cancer
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Expert Guidelines
The National Comprehensive Cancer Network (NCCN) brings together panels of national expert to create guidelines for cancer treatment. NCCN breast cancer guidelines recommend the following treatments for people with metastatic breast cancer:
- For hormone receptor-positive cancers, the NCCN recommends several different treatment options:
- Hormone therapy with HER2-targeted therapy (for people who are post-menopausal or take drugs to suppress their ovaries).
- HER2-targeted therapy with chemotherapy.
- For hormone receptor negative cancers:
- HER2-targeted therapy with chemotherapy.
- For 2nd-line therapy:
- Trastuzumab deruxtecan (ENHERTU) is the preferred treatment.
- Tucatinib (Tukysa) with HER2-targeted therapy and chemotherapy (for people with to the brain or other parts of the central nervous system).
- For 3rd-line and later therapy:
- Tucatinib (Tukysa) with HER2-targeted therapy and chemotherapy (especially in people with to the brain or other parts of the central nervous system).
- HER2-targeted therapy with chemotherapy.
Updated: 12/22/2021
Questions To Ask Your Doctor
- Is Tuksya a treatment option for my type of breast cancer?
- If Tukysa is not an option for me right now, might it be an option in the future?
- What side effects might I experience with this treatment?
- If I have serious side effects, will I need to stop treatment?
- Are any other agents available to treat my cancer?
Open Clinical Trials
The following are studies looking at treatment for people with HER2-positive breast cancer.
- NCT05458674: Tucatinib+Trastuzumab+Eribulin in HER2+ MBC. This study will evaluate the safety and efficacy of the three-drug combination of tucatinib, trastuzumab, and eribulin in patients with unresectable HER2-positive breast cancer after prior treatment with a taxane, trastuzumab, and T-DM1.
- NCT06100874: A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN). This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in HER2+ breast cancer.
- NCT03368729: in Combination With Trastuzumab in HER2+ Breast Cancer. This study will evaluate , a type of known as a . will be combined with trastuzumab, an anti-HER2 agent, to evaluate the safety and tolerability in patients with HER2 positive breast cancer.
- NCT06435429: A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With HER2-positive Breast Cancer. The efficacy and safety of zanidatamab in combination with chemotherapy compared with trastuzumab (Herceptin) in combination with chemotherapy will be evaluated for the treatment of participants with HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.
- NCT05378464: Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ HER2+ Breast Cancer. This study will test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with positive breast cancer.
- NCT05894239: A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus in Combination With Phesgo in Participants With PIK3CA-Mutated Locally Advanced or Breast Cancer. This study will look at the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection) compared with in combination with Phesgo, as , after induction therapy in participants with previously untreated advanced breast cancer (ABC).
Other clinical trials for people with breast cancer can be found here.
Updated: 09/12/2024
Peer Support
The following organizations offer peer support services for people with, or at high risk for breast cancer:
- FORCE peer support:
- Our Message Boards allow people to connect with others who share their situation. Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Our Peer Navigation Program will match you with a volunteer who shares your mutation and situation.
- Connect online with our Private Facebook Group.
- Join our virtual and in-person support meetings.
- Other organizations that offer breast cancer support:
Updated: 05/07/2024
Related Resources
The following organizations have resources related to breast cancer.
- FORCE related resources:
- Information: Breast cancer screening and prevention
- Information: Breast cancer treatment
- Personalized portal: Breast cancer
- XRAY category: Breast cancer
- XRAY category: breast cancer
- Video playlist: Breast cancer
- Blogs: Breast cancer
- General breast cancer resources:
- breast cancer resources:
- Male breast cancer resources:
- Resources for Black, Indigenous and People of Color:
Updated: 05/22/2024