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Faslodex + Capivasertib vs Placebo in Metastatic, ER positive Breast Cancer

Published February 5, 2020

Background

Capivasertib (AZD5363) is an oral inhibitor of AKT and by that it influences cell division, apoptosis and cell metabolism. The FAKTION study investigated whether the addition of Capivasertib to Faslodex prolonged the time until disease progression in metastatic or locally advanced inoperable breast cancer patients who failed and developed resistant to Aromatase Inhibitors, such as Arimidex, Femara and Tamoxifen.

Methods

This clinical trial, The FAKTION study, was a Phase II trial and recruited breast cancer patients from 19 hospitals in the UK. Enrolled participants were randomly assigned (1:1) to receive Faslodex with either Capivasertib or Placebo, orally twice daily.

Findings

Median time until disease progression was 10·3 months in the Capivasertib group versus 4·8 months in the placebo group and the risk of disease progression had decreased by 42% in the Capivasertib group.

Adverse Events

The most common adverse events in the Capivasertib group were hypertension, diarrhoea, rash, infection and fatigu.

Serious adverse reactions occurred only in the Capivasertib group and were acute kidney injury, diarrhoea, rash, hyperglycaemia, loss of consciousness, sepsis and vomiting. One death, due to atypical pulmonary infection, was assessed as possibly related to Capivasertib treatment. One further death in the Capivasertib group had an unknown cause.

Conclusion

The addition of Capivasertib to Faslodexwas associated with a significant median prolongation of the time until the disease had progressed 10.3 vs 4.8 months compared with Faslodex alone.

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For further reading

 

About Breast Cancer

One out of seven women will develop breast cancer sometime throughout her life. Approx. 1% of all breast cancer cases appear in men.

Breast cancer is diagnosed following taking a biopsy or removal of cells from the afflicted tissue during surgery and diagnostic analysis.

Early detection affects the disease treatment plan and also treatment success.

The existing therapies used for stage 4 metastatic breast cancer are not curative, and this is a source of the need for innovative and effective treatment strategies in order to fight the disease.

The National Cancer Institute, NCI, highlights the fact that for a certain group of breast cancer patients, the best treatment option is to join one of the many clinical trials existing worldwide aiming to increase their chances of therapeutic success.

Classification

The disease is classified according to the breast cells from which it develops. In most cases the source is the epithelial cells in the breast tissue, thus the disease is called “Adenoarcinoma”.

In some cases, the disease develops in the milk ducts which transfer milk from the glands to the nipples (milk ducts or the milk ducts that produce milk, lobules).

The disease can be local, locally spread or metastatic, which is also called “Stage 4”.

Types of breast cancer

Breast cancer is classified according to the type of receptors found on the cell. A “receptor” is a molecule located on the external shell of the cancerous cell to which ligands bind. A “ligand” is a molecule smaller than the receptor that triggers intracellular biological processes including proliferation and survival processes of the cancerous cells.

Stage 4 breast cancer

Stage 4 metastatic breast cancer is a cancer that started in the breast and its cells have spread to other body organs, distant from the breast, and created new lesions. These lesions are called “metastases” and are made of breast cancer cells.

Breast cancer metastases may appear in the bones, liver, lungs and brain. The formation of metastases constitutes a threat on life.

Even though the cancer has spread to other organs, it is still defined as a breast cancer and is treated as breast cancer. In this manner for example, a lesion in the lung that is a metastasis of breast cancer shall be treated with breast cancer drugs and not lung cancer drugs.

Breast cancer metastases may appear in the bones, liver, lungs and brain

Symptoms

  • A lump in the breast that is palpable
  • A swelling of the breast or the armpit area
  • A change in the breast appearance or a drop of the breast
  • Reddish, inflamed and rough looking (“orange peel” texture) or irritated breast skin
  • The nipple is enlarged, bleeding, swollen, inflamed or retreating in

Facts

The existing therapies used on stage 4 metastatic breast cancer are not curative, and this is a source to the need for innovative and effective treatment strategies in order to fight the disease.

The National Cancer Institute, NCI, highlights the fact that for a certain group of breast cancer patients, the best treatment option is to join one of the many clinical trials existing worldwide aiming to increase their chances of therapeutic success.

Currently, every patient will be offered the standard protocols described above. Sometimes the oncologist may suggest integrating these therapies with trials carried out in the institute.

 

#cancer #breastcancer

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