Metastatic breast cancer treatment

Patients with HER2+ metastatic or locally recurrent unresectable breast cancer that has spread to other parts of the body may be given SIGRIMA™ along with Trastuzumab and docetaxel as initial treatment.1,2

This will be given to patients who have not received any anti-HER2 therapy or chemotherapy for metastatic breast cancer.2

Diagnosis

Stage 4

Metastatic treatment

It is to be noted that although metastatic breast cancer is treatable and the goal of treatment is to help control cancer growth, it is usually not curable.1,3

Who can receive SIGRIMA™?

Patients with HER2+ metastatic or locally recurrent unresectable breast cancer can be given SIGRIMA™ and Trastuzumab-based therapy if:

How SIGRIMA™ + Trastuzumab-based therapy may help?

Study Protocol

The study enrolled 268 patients with metastatic breast cancer. The results demonstrated that patients who received Test Pertuzumab (SIGRIMA™) experienced comparable efficacy, safety, pharmacokinetics and immunogenicity to those given Reference Pertuzumab (Perjeta®, a product of Genentech, Inc.) over a duration of 155 days (approximately 22 weeks). This duration included a 4-week screening period and a 106-day treatment period with 6 cycles of 21 days each.

Efficacy Comparision

In patients with metastatic breast cancer, post 6 cycles of treatment, the study found that SIGRIMA™ was just as effective as the reference product Perjeta.5

Safety Comparision6

TEAE, treatment-emergent adverse event. If a subject has multiple occurrences of an AE or TEAE, the subject is presented only once for the corresponding AE or TEAE.6 N = number of subjects in specified treatment; n = number of subjects having non-missing values.6 The percentage calculated by (n/N)*100.6

Side Effects May Occur With SIGRIMA™

What are the most serious side effects of SIGRIMA™?

  • Treatment with SIGRIMA™ during pregnancy can harm the fetus, leading to death of the fetus, or may cause major birth defects.2
  • SIGRIMA™ can cause heart problems, such as reduced heart function, which is asymptomatic, and congestive heart failure, which is symptomatic.2

What are the most serious side effects of SIGRIMA™?

  • SIGRIMA™ should be avoided in patients who are allergic to Pertuzumab or to any of the ingredients present in the SIGRIMA™ formulation.2
  • Serious or fatal side effects may be related to infusion or allergic reactions (anaphylaxis/hypersensitivity).2
  • The most common side effects of SIGRIMA™ in combination with Trastuzumab and docetaxel are low white blood cell count levels with or without fever, diarrhea, hair loss, excessive tiredness, nausea, rashes, and nerve damage causing weakness, numbness, and tingling in hands and feet.2

Your side effects may differ depending on your chemotherapy regimen.1

Important Safety Information

Are there any side effects of SIGRIMA™ I should look out for?

While the severe side effects of SIGRIMA™ are not experienced by everyone, side effects from SIGRIMA™ are common.1 So, it is important for you to know the symptoms and side effects one should look out for.

In case the side effects start becoming more serious, your doctor may stop the treatment. This is why you shouldimportantsafety report the side effects you are worried about to your doctor, and be sure to ask all your queries regarding the treatment.

Important Safety Information & Uses