If this file opens in Compatibility Mode using Microsoft Word, convert to the latest document format to avoid potential formatting issues.	

OP RSH PRO00038015 TEMPLETON TAXIS PRE TRIAL PHASE	

Types:      Research Oncology Treatment
Synonyms:  TAXIS, PRO00038015, AXILLARY SURGERY

Baseline /Screening pre registration	Repeat 1 time	Cycle length: 28 days	PR : pre-registration 	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Informed consent for trial participation
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Imaging
  	MAMMO DIGITAL DIAGNOSTIC BILATERAL	Interval: --	Occurrences: --		  	US AXILLA BILATERAL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Histological or cytological confirmation of breast cancer
			Procedures
  	BIOPSY	Interval: --	Occurrences: --	Comments:	Biopsy / clipping

If standard treatment (per protocol)
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Staging according to local standards
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	8 w to Registration 

On PR if neoadjuvant treatment administered
				2W to registration 	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Medical history
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	2w to registration.

After neoadjuvant treatment. Optional
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Quality of Life (QOL) assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Recording of neoadjuvant and adjuvant systemic treatments (if indicated).

According to internatl. guidelines
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

Continuously. 
Document from date of patient consent signature up to 10 years after randomization