Guideline: FDA issues alert on a drug combination to treat triple-negative breast cancer
|At a glance||Clinical trials|
|Why is this alert important?||Guidelines|
|What is Tecentriq||Questions for your doctor|
|What does this mean for me?||Resources|
This alert is about:
A Food and Drug Administration () alert warning health care providers, researchers and patients that Tecentriq (atezolizumab) should not be combined with Taxol (paclitaxel) to treat patients with advanced ().
Abraxane is not Taxol
Abraxane and Taxol are similar chemotherapy agents. Abraxane is a modified form of Taxol. It has a protein bound to it to help it get into cancer cells. While similar, Abraxane and Taxol are different drugs and they may act differently when used to treat cancer.
This alert is for patients and their doctors. It warns against combining two approved treatments for advanced . While Tecentriq and Taxol are approved to treat some types of advanced , the drugs are not approved to be used together.
Tecentriq is a type of known as an "immune checkpoint inhibitor." It is approved for treating people whose triple-negative breast cancer makes a known as “ (programmed death-ligand 1”. is a protein that helps cancer cells avoid detection by the immune system. The has approved the VENTANA (SP142) to see if treatment with Tecentriq would be beneficial for individual patients. This test looks for in cancer cells and is used to find tumors that are most likely to respond to Tecentriq.
On March 8, 2019, the U.S. Food and Drug Administration () granted accelerated approval of Tecentriq in combination with the chemotherapy agent Abraxane for advanced . This approval was the result of the IMpassion 130 trial which showed that this drug combination improved progression-free survival in patients with advanced . Learn more about the results of the IMpassion 130 trial here.
On September 8, 2020, the warned that Abraxane should not be replaced with Taxol to treat patients with advanced . The results of the IMpassion 131 trial prompted this alert. The trial found no benefit of Tecentriq combined with Taxol compared to Taxol alone in patients with advanced .
The continually reviews data from drug trials and reports any potential changes in prescribing information. The IMpassion 131 trial results are preliminary. While trial enrollment is closed, researchers continue to gather new data on participants. The will review these results along with data from other trials that are also looking at the use of Tecentriq combined with Taxol and recommend additional changes if appropriate.
The approval of Tecentriq combined with Abraxane has not changed. This drug combination is approved for treatment of some women with advanced . The is warning patients and health care providers not to combine Tecentriq with Taxol for patients with advanced because it does not appear to benefit them. Tecentriq combined with Taxol is approved for other cancers. Patients taking Tecentriq combined with Taxol for other approved indications should continue as directed.
Tecentriq is the first immune checkpoint inhibitor drug approved for breast cancer. If you have been diagnosed with locally advanced or triple-negative breast cancer, you may want to talk to your doctor about tumor testing and whether the Tecentriq plus Abraxane treatment combination is right for you.
Talk to your health care provider if you have any concerns or questions about your breast cancer treatment. If you have any adverse events or side effects related to treatment with Tecentriq in combination with Abraxane, consider completing the ’s MedWatch Online Voluntary Reporting form.
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The National Comprehensive Cancer Network (NCCN) brings together national expert panels that create guidelines for cancer treatment. The guidelines for advanced or TNBC includes the following:
- Genetic testing:
- All people diagnosed with at any age meet guidelines for genetic counseling and testing.
NCCN lists the following as preferred treatments for TNBC:
- NCCN lists several different chemotherapy combinations.
- NCCN lists Sacituzumab govitecan-hziy (Troveldi) for treatment in people who have received at least two prior lines of treatment, with at least one treatment line for breast cancer.
- Targeted therapy:
- NCCN lists (Lynparza) or () for people with an inherited or mutation.
- NCCN lists Pembrolizumab as a preferred therapy for people with tumors that test positive for expression.
- Does this alert affect my treatment?
- How can I have my breast cancer tested for ?
- Are other tumor tests available to help guide my treatment?
- Is the Tecentriq plus Abraxane combination treatment an option for my breast cancer?
- What side effects may I experience with Tecentriq plus Abraxane combination treatment?
- Are there other agents that may be used to treat my cancer?
The following are studies looking at new treatments for people with TNBC.
- NCT03606967: Testing the Addition of an Individual Vaccine to Nab-Paclitaxel, Durvalumab and Tremelimumab and Chemotherapy in Patients With Triple Negative Breast Cancer. This study will look at how well the combination of chemotherapy, and when used with or without a vaccine made specifically for each patient.
- NCT04468061: Saci-IO TNBC: Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative TNBC. This early phase study is looking at how safe and effective Trodelvy with or without Pembrolizumab is in patients who have that has spread to other parts of the body.
- NCT04020575: Using a Type of Called CAR-T to Treat Triple-Negative Breast Cancer. This study will look at how safe and how well a type of treatment made from the patient's cancer works for treatment certain types of breast cancer.
- NCT03971409: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With IV or Unresectable, Recurrent (InCITe). This studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating TNBC that has recurred.
- NCT04491942: Testing a in Combination with Chemotherapy for Advanced . This study looks at how well a new drug called elimusertib works when combined with chemotherapy for treating people with triple-negative breast cancer and other advanced cancers.
- NCT04837209. Radiation, and in Triple Negative Breast Cancer (NADiR). This research study is looking to see whether the combination of Dostarlimab and plus Radiation Therapy (RT) is safe and effective in participants with triple negative breast cancer.
- NCT05081492: Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and (Pembrolizumab) for Triple-Negative Breast Cancer. This study is looking at the safety, side effects, and best dose of a drug called CF33-hNIS-antiPDL1 in treating patients with triple negative breast cancer. CF33-hNIS-antiPDL1 is a virus that is designed to attack and kill cancer cells.
A number of other clinical trials for treating patients with TNBC can be found here.