Clinical Trial Information Sheet - LOBSTER

Primary Indication

Breast cancer

 

Study Name (Study Type)

LOBSTER

Neoadjuvant Phase II Study 

Study sponsor

AstraZeneca 

Registration number

EUCT: 2023-509292-17-00

FOR SKIMMERS:

LOBSTER is a Phase II study evaluating the drug capivasertib in combination with the endocrine therapy fulvestrant compared to fulvestrant alone.

DETAILED INFORMATION:

This study is a randomized, open-label Phase II trial. Randomized means that a computer program randomly assigns each participant on a 1:1 basis to either the Capivasertib + Fulvestrant arm or the Fulvestrant arm. 

Open-label means that each participant, their doctors, and the study staff know which treatment the participant is receiving.

For 10 weeks prior to surgery, patients will receive either fulvestrant (intramuscular injection) in combination with capivasertib (tablets) or fulvestrant alone. During their participation in the study, patients should attend regular visits at their study center. These visits take place before the start of the study (the so-called “screening phase”), during treatment with the investigational drug (the so-called “treatment phase”), and after the end of treatment with the investigational drug (the so-called “follow-up phase”). 

Study Title

Neoadjuvant Phase II Study to Evaluate Capivasertib Plus Fulvestrant Compared to Fulvestrant Alone in Patients with Primary Lobular Breast Cancer and a High Risk of Recurrence

Which conditions are being treated in this study?

Breast cancer

Are specific subgroups of patients with one of the mentioned conditions being treated?

Patients with early-stage, hormone receptor-positive, HER2-negative lobular breast cancer.

Background on the study medication

Fulvestrant belongs to the class of estrogen blockers. Estrogens are female sex hormones and may play a role in the growth of breast cancer. It inhibits the growth of breast cancer cells by reducing the number of estrogen receptors. Fulvestrant is approved in Europe for the treatment of postmenopausal women with estrogen receptor-positive locally advanced or metastatic breast cancer

Capivasertib is an AKT inhibitor and is administered in tablet form. It blocks a signal that cancer cells typically use to grow and multiply. This signal is known as the AKT signaling pathway. The AKT signaling pathway plays a crucial role in resistance to endocrine therapies such as fulvestrant. Capivasertib is approved in the United States, in combination with fulvestrant, for the treatment of patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.

Study Design

This study will enroll approximately 120 participants with high-risk
primary lobular breast cancer at stages ≥ cT2 or
cT1c and cN+.

Inclusion Criteria

• Postmenopausal women who were ≥ 18 years of age at the time of diagnosis
• Unilateral or bilateral primary, untreated lobular invasive breast
  carcinoma
• No distant metastases.

Exclusion Criteria

• Patients with any contraindications
• The patient is currently participating in a clinical trial and is receiving active treatment
• Any prior treatment, including endocrine therapy, chemotherapy,
  radiation therapy, or targeted therapy (including AKT inhibitors or PIK3 inhibitors)
• Excisional biopsy or lumpectomy for the current disease
• Ipsilateral surgical procedure for staging in the axilla, including sentinel lymph node
  biopsy 

Your Points of Contact: Investigators at the Center and Contact Information

Dr. Andriana Haus

Email: haus@~@gp-ruesselsheim.de

Phone: 06142 88-1223

Contact the study clinic

Email: Studienzentrale@-ruesselsheim.de

Phone: 0162-1392714