Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Disease Progression

Breast Diseases

Skin Diseases

Menopause

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Estrogens

Goserelin

Antineoplastic Agents, Hormonal

Zoladex 10.8 mg (goserelin acetate) will be injected once every 12 weeks (± 7 days).

One oral tamoxifen 20 mg tablet also will be taken daily

Zoladex 3.6 mg (goserelin acetate) will be injected once every 4 weeks (± 7 days). One oral tamoxifen 20 mg tablet will also be taken daily.

10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).

ZD9393 (Zoladex) 10.8 mg

3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).

ZD9393 (Zoladex) 3.6 mg

Justin Lindemann, PO

The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with estrogen receptor positive advanced breast cancer who were randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.

Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer

An Open Label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX™ 10.8 mg Given Every 12 Weeks With ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-menopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer.

A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.

Responders are defined as those patients with a best objective tumour response of CR or PR during the first 24 weeks of therapy. Tumour response is assessed according to the RECIST version 1.1. ORR is defined as the proportion of patients who are responders.

E2 serum concentrations (pg/mL) at 24 weeks

AstraZeneca

ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks

Zoladex 10.8 mg

ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks

Zoladex 3.6 mg

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Asia

Region of Enrollment

Global Clinical Lead

CI for the difference (10.8 mg-3.6 mg) in %PFS at 24 weeks calculated using the score method recommended by Newcombe et al

Number of Patients With Progression-free Survival (PFS) at 24 Weeks

CI for the difference (10.8 mg-3.6 mg) in ORR at 24 weeks calculated using the score method recommended by Newcombe et al

Full Analysis Set (patients without measurable disease at baseline were excluded from analysis)

Number of Responders at 24 Weeks

Oestradiol (E2) Serum Concentrations at 24 Weeks

Overall Study

Aromatase Inhibitors

Patients will receive 40mg of Irosustat once daily in addition to the aromatase inhibitor on which they progressed until disease progression or the development of unacceptable toxicities.

Patients will receive 40mg of Irosustat once daily in addition to the aromatase inhibitor on which they progressed until disease progression or development of unacceptable toxicities.

Irosustat

Carlo Palmieri

70% of breast cancers that occur in postmenopausal women rely on the hormone oestrogen to grow and are likely to respond to hormone treatment. This type of treatment reduces the amount of oestrogen in the body, slowing the growth of cancer or stopping it altogether. One type of hormone treatment, aromatase inhibitors (AIs), works by stopping the body from making oestrogen. Currently, women with locally advanced or metastatic breast cancer that is not being controlled by one class of AI are switched to the other class of AI. The reason for this is that some cancer cells can become resistant to one class but are still sensitive to the other class. However, oestrogen can be made in the body by two pathways and AIs block only one of these pathways. A new drug called Irosustat can reduce the production of oestrogen in the body by blocking the second pathway. This study is investigating whether adding Irosustat to AI treatment i.e. blocking both pathways at the same time, can further reduce the amount of oestrogen in the body and therefore control the breast cancer better.

27 postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer that is not being controlled by their current AI treatment will be recruited in this study from 9 United Kingdom (UK) hospitals. Eligible patients will receive 40mg of Irosustat once daily in addition to the AI on which they progressed. Patients will receive Irosustat for as long as it controls their cancer or until they have side effects that stop them from taking treatment. Patients will be seen monthly for the first 6 months and every 3 months thereafter. Participating patients will also be given the option to take part in the exploratory part of this study by donating tissue and blood samples.

A Study of the Safety and Effectiveness of Irosustat When Added to an AI in ER+ve Locally Advanced or Metastatic Breast Cancer.

A Phase II Study to Assess the Safety and Efficacy of the Steroid Sulfa-tase Inhibitor Irosustat When Added to an Aromatase Inhibitor in ER Positive Locally Advanced or Metastatic Breast Cancer Patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer	NCT01073865	Breast Cancer	ZD9393 (Zoladex... ZD9393 (Zoladex...	20 Years - 130 Years	AstraZeneca
A Study of the Safety and Effectiveness of Irosustat When Added to an AI in ER+ve Locally Advanced or Metastatic Breast Cancer.	NCT01785992	Locally Advance... Metastatic Brea...	Irosustat	25 Years -	Imperial College London
A Study of the Safety and Effectiveness of Irosustat When Added to an AI in ER+ve Locally Advanced or Metastatic Breast Cancer.	NCT01785992	Locally Advance... Metastatic Brea...	Irosustat	25 Years -	Imperial College London

Spots Global Cancer Trial Database for oestrogen receptor