Response to Optimal Selection of neo-adjuvant Chemotherapy in Operable breast cancer

• Conditions: Breast cancer; MedDRA version: 17.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004307-39-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-21
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

ROSCO Main Trial
• Patient with histological diagnosis of invasive breast cancer
• Suitable for neo-adjuvant chemotherapy in opinion of investigator
• Unifocal tumour:
- Radiological size greater than or equal to (=) 20 mm by ultrasound (or in some cases Magnetic Resonance Imaging (MRI) is allowed)
- T4 tumour of any size with direct extension to (a) chest wall or (b) skin or both
- Inflammatory carcinoma with tumour of any size
OR
Multifocal tumour:
?- The sum of each tumour’s maximum diameter must be =20 mm (total sum of multifocal deposits =20 mm by ultrasound)
OR
Other locally advanced disease
- Biopsy confirmed axillary lymph node involvement or large or fixed axillary lymph nodes (radiological diameter =20 mm or clinical N2), or ipsilateral supraclavicular nodes and primary breast tumour of any diameter
- Involvement of large or fixed axillary lymph nodes (radiological diameter =20 mm or clinical N2), or ipsilateral supraclavicular nodes without a primary breast tumour identified: in this case the presence of breast cancer in a lymph node must be histopathologically confirmed by lymph node biopsy (trucut or whole lymph node)
• Patients with bilateral disease are eligible to enter the trial, if one of the criteria above is met for disease in at least one breast
• Any HER2 status
• Patient fit to receive the trial chemotherapy regimen in the opinion of the responsible clinician. The following recommendations must be taken into account when making this assessment:
- Patients with HER2 positive disease must not have clinically significant cardiac abnormalities. Cardiac function should be assessed by physical examination and baseline measurement MUST be made of Left Ventricular Ejection Fraction (LVEF) by Multi Gated Acquisition (MUGA) scan or echocardiogram (ECHO). LVEF must be within the normal range as defined locally by the treating hospital
- Patients must have adequate bone marrow, hepatic, renal and haematological function
• Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
• Women of child-bearing potential, or men in a relationship with a woman of child-bearing age, prepared to adopt adequate contraceptive measures if sexually active
• 18 years or older
• Male or female
• Written informed consent for the trial
• Availability of embedded paraffin tumour blocks from pre-chemotherapy biopsy is required
• Willing and able to comply with scheduled visits, treatment plan and other study procedures
Sentinel Lymph Node Biopsy Study (in addition to above)
• Biopsy/fine needle aspiration proven involved ipsilateral axillary lymph nodes at diagnosis

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

ROSCO Main Trial
• Tumours of low or intermediate grade (Grade 1 or 2) which are also Oestrogen Receptor (ER) rich and Progesterone Receptor (PgR) rich or PgR unknown, whatever the size or nodal status
• Previous invasive breast cancer
• Unequivocal evidence of metastatic disease
• Previous diagnosis of other malignancy unless:
- Disease-free for 5 years; or
- Previous basal cell carcinoma, cervical carcinoma in situ, superficial bladder tumour; or
- Contralateral or ipsilateral DCIS of the breast treated by surgery alone
• Previous chemotherapy
• Prior extensive radiotherapy (as judged by the investigator) to bone marrow
• Previous neo-adjuvant endocrine therapy (unless less than 6 weeks duration)
• Concomitant hormonal therapies/chemotherapy or any other medical treatment in relation to treating the breast cancer
• In HER2 positive patients risk factors precluding co-administration of trastuzumab and FEC75
- Previous myocardial infarction during the 6 months prior to recruitment
- LVEF below institutional lower limit of normal and no echocardiographic evidence of heamodynamically
- Significant valvular heart disease or ventricular contractility
• Prior diagnosis of cardiac failure
• Uncontrolled hypertension, coronary heart disease other significant cardiac abnormality
• Bleeding diathesis
• Presence of active uncontrolled infection
• Any evidence of other disease which in the opinion of the investigator places the patient at high risk of treatment related complication
• Pregnant (female patients of child bearing potential should have a urine or blood Human Chorionic Gonadotropin test performed to rule out pregnancy prior to trial entry)
• Lactating females
• Any concomitant medical or psychiatric problems which in the opinion of the investigator would prevent completion of treatment or follow-up

Sentinel Lymph Node Biopsy Study (in addition to above)
• Negative nodes at diagnosis
• SLNB at diagnosis
• Allergy to patent blue dye

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified