Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Drug-AZD8931

Placebo comparator for biological activity comparison

Drug-Placebo

Serban Ghiorghiu, M.D.

To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours

A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients with Early Breast Cancer who are Ineligible for Treatment with trastuzumab as defined by IHC status

Evaluation of Drug Activity in Women With Breast Cancer and no Previous Herceptin Treatment

A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients With Early Breast Cancer Who Are Ineligible for Treatment With Trastuzumab as Defined by IHC Status

AstraZeneca

Behaviors and Mental Disorders

Carcinoma

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Quality of Life

Accelerated partial breast irradiation utilizing 3D-CRT

APBI utilizing 3D-CRT radiation

Whole breast irradiation

Tim Whelan, MD

Ivo Olivotto, MD

Mark Levine, MD

To determine if Accelerated Partial Breast Irradiation, using 3D CRT, is as effective as Whole Breast Irradiation following breast conserving surgery in women with an new histological diagnosis of ductal carcinoma in situ only or invasive breast cancer without evidence of metastatic disease. Effectiveness will be determined by the rate of ipsilateral breast tumour recurrence.

General objective is to improve the convenience and quality of life of female patients who receive breast irradiation.

Following breast conserving surgery or on completion of chemotherapy, patients will be stratified according to age, tumour histology, tumour size, adjuvant hormonal therapy and clinical centre. Patients will be allocated to receive either whole breast irradiation or 3D CRT accelerated partial breast irradiation.

Radiation therapy will be administered as soon as possible following the healing of the surgical incision (3-4 weeks) and within 12 weeks if the patient is not treated with chemotherapy. If the patient is treated with chemotherapy, radiation therapy will begin after 2 weeks and not beyond 8 weeks after the last dose of chemotherapy.

Patients treated with whole breast irradiation will receive a total dose of 42.5 Gy in 16 fractions, given on a daily basis, over a time period of 22 days. Patients with large breast size are permitted to receive a total dose of 50 Gy in 25 fractions, given on a daily basis, over a time period of 35 days. Boost irradiation is permitted in patients treated with whole breast irradiation. Boost irradiation of 10 Gy/4-5 fractions daily over a time period of 4-7 days is permitted for patients deemed at moderate to high risk of local recurrence as per local cancer centre guidelines.

Patients treated with 3D CRT accelerated partial breast irradiation will receive a total dose of 38.5 Gy in 10 fractions, delivered twice a day, over a time period of 5-8 days. Each daily dose must be separated by 6-8 hours.

Patients will be followed indefinitely and assessed formally at 6 and 12 months after the date of randomization and then on a yearly basis. Patients will be assessed for acute and late radiation toxicity, cardiac toxicity, recurrent disease, new primary cancer, cosmetic outcome, quality of life and overall survival.

RAPID: Randomized Trial of Accelerated Partial Breast Irradiation

An RCT to Determine if APBI, Utilizing 3D CRT, is as Effective as Whole Breast Irradiation Following Breast Conserving Surgery in Women With Ductal Carcinoma in Situ or Invasive Breast Cancer With Negative Axillary Lymph Nodes

Canadian Institutes of Health Research (CIHR)

Canadian Breast Cancer Research Alliance

Ontario Clinical Oncology Group (OCOG)

PD L 506

This is an explorative phase II study to investigate the suitability of PD L 506 in the specific intra-operative detection of breast tumour tissue.

Fluorescence-guided Resection in Breast Cancer

Evaluation of the Suitability of PD L 506 for Intraoperative Visualisation of Palpable and Nonpalpable Breast Cancer Tissue

photonamic GmbH & Co. KG

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Drug Activity in Women With Breast Cancer and no Previous Herceptin Treatment	NCT01596530	Breast Neoplasm	Drug-AZD8931 Drug-Placebo	18 Years -	AstraZeneca
RAPID: Randomized Trial of Accelerated Partial Breast Irradiation	NCT00282035	Breast Cancer	APBI utilizing ... Whole breast ir...	40 Years -	Ontario Clinical Oncology Group (OCOG)
RAPID: Randomized Trial of Accelerated Partial Breast Irradiation	NCT00282035	Breast Cancer	APBI utilizing ... Whole breast ir...	40 Years -	Ontario Clinical Oncology Group (OCOG)
Fluorescence-guided Resection in Breast Cancer	NCT01110954	Breast Tumour	PD L 506	18 Years -	photonamic GmbH & Co. KG

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