Clinical trial: NCT01417286
Section: Alternatives
Subsections: Are There Benefits To Taking Part Iu This Study?

Taking part in this study may ornlsy not make your health better. While doctors h6pe thar A-pMRl' will be at lcasl as cffective in preventing bruast oaoccr recurrsnces ns skrndarrl pMK;, thcrc is no proof of this yet. One benelit of this treatrnent is the reduced overall heatment timc. \Ve do know that the information from this study will help doctors leam more about accelerated pMRT as a treefinent for brEast cancer. This information could he$ future cancer paLienls.  
What othcr choices do I havo if f do not tnke part in this study?  
Your o*rer choices may include:  
r Receiving standard PMRT over 6 rvseks without being in this sludy r Getting treatnent or oare for your cimcer without being in dris study
. Takiry pmt in another stucly
. Getting no radiation treatrre.nt
Please talk witl your doctnr about your choices befbre you decicle if you rvill urke part in tlis stucly.
Clinical trial: NCT01417286
Section: Confidentiality
Subsections: Will My Medical Information Be Kept Privnte?

We will do our best to make suru that the personal information in yom rnediual reeord will be kept private' Hou'ever, we cannot guarantee total privacy" lnfr:rrnation for this trinl will be kept on-a secure password-protected computer that u,ill allow access to only {he snrdl' personnel. your rtxptfiH$
I- TiFIJHSVSil  
Paee I of l0  
Al'i l} ft l,i'f, IBB{I0220100204  
VersionDate: IULA]3  
I ,' r,j .1 tl ,  
,i. r  
Accelerated, Ilypokactionated Posr*Ivfastwtoury ltadiation Therapy in Womon with Br$ast Cancer: A phase II Irial ry:pg]n:e$e!n per$onal infor:nation may [:e given out if requirecl by lalv, If inftrrmation from this study is published or presentcd at scientilic mectings, ycirr narne aud other pcrmnal igform.ation rvill not be usod.  
Organizations that may look at anti/or copy your medical records for re,seareh, for qgality &ssurance,  
  
and data aulysis include:
Clinical trial: NCT01417286
Section: Duration of Study Involvement
Subsections: Iiow Longwill I Be In The *Turty?

You will be on study from the tirns consent is signed until the end of radiation treatments. This total time should be less ihar, 8 weeks, wi,th the radiation la.stiug less than 30 days. ,At the end of rartiation thcapy, y-ou will continue seeing your surgc$n, medical oncologist or radii*ion onoologist as noted helorv, Eihich is pan of the nr:rmal follow-up fbr n caucer palient. Patients rvill be resn in follnn up weekly during treaklenl, at the cud of radiation, then 2-8 rvceks aftsr radiation treatments. then every 3-6 months fitr 3 years, then every 6-12 months out to 5 ycars.  
During tho first hro yetrs after finishiag &e study, you will have the following tests and procedures performul:
; A brieJ' hisktry anrl physical exam at the end of radiation tlrcrapy, then at week 2-8 after rarliatiorr therapy, thenevery 3-6 months fbr the fust 3 y"ears.  
During 3-5 years aflrr finishing the stucly, you will have the following tests and procerlures per{trrmed:
t A hrief history and physical exom and tm examination o/ your ahest wall will be perfurmed every 6-LZ months afler finishing radiatioa therapy, or n{ter tinishing radiation therqpy and chemotherapy, i f rcceived.  
After the 5th ycar after linishing the study, a bric.f history and physical exarn will bc pcrformed at a schedule decided upon by yorr trsating doctors.
Clinical trial: NCT01417286
Section: Participant's Rights
Subsections: Whut Nre My Rights If I Take Part In Thiu Study?

Taking part in thi.s study is your choice. You may chooss cither to take purl. or not to take part in the study. If you decide to take prrrt in this study, yolr may luavc the study at any tiure. No mirtter what dccision you rnake, therc will be uo penalty to you and you rvili not lo.so any of yorr regulir beuefits.  
Leaving the study will nol alfect your medical care. You cm still get your metlical care from our institution.  
trxptHfr.* ffi Yursion Date; l21l2i I i  
| trxptHfr.*                   |              |
|------------------------------|--------------|
| ffi Yursion Date; l21l2i I i | Paec 9 of l0 |
| iil,j ti lj i,i:l            |              |  
The Data Monitorirrg Conunittee (DMC), an irrdepcndent group of expe.rts, will be reviewing the da{a liom this rcsearch throughout the study. We *ill fell you about new information or changes in the study lhat may rffect your hcalth 0r your willingne.rs to continue in the study. You may be osketl to sign moths consent fonrr in ro$ponse to now inforrnation.  
ln the case of injury resulling from this study, you do not lose any of your legal riglrts to seek paymeft by signing this form.  
lVho can an$rer my questions about the study?  
you may have about this study.  
You can talk to dootor about any quostion or conc€rfis r You may call the National Curcer lnstitute's (NCls) Cancer Informaiion Service at:
1 - 8004-CANCER ( 1 -800 -422-5237)
You rnayalso visit the NCI Web Site at httf://csngsr.gov For the NCI's clinical trials in&mration, go m: M
For the NCI's general infirrmation about carccr, go to: htpr//gpnc$,suy/octtqEriufo You will rscsive a copy of this form. If you want more infornnation about this study, ask your study dookr.
Clinical trial: NCT01417286
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What *Ide Elfccts Or Risk$ C&N I Erpect Frour Being In The Shrdy?|Risk Related Totertility Afid Pregrruacy|What Happens If I Arn Injurcd Because I Toolfmrt H This Study?

You may bave side effects while on this shrdy. Most of thesc are listerJ herc, birt there may be other side effects that we c&urot pJsdict Side effects will vary tom percon to persoa. Everyone taki,g putt in the study will be carefully watched for any side eflbcts. However, doctom do not know all tlrc.sidc elfsof,s that may happen. Side effects may be mild or very serious. Your hcalth care team may glve you medications to help lesscn .goms ol'the side effects. Many side effccts go a\f,,ay soon afier your radiation therapy. In some cas€s, side effects may be vcry serious, longJastilg, o, *uy heYer go alvay.  
You should t&lk with your study doctnr about any side effests that you may have w,hile taking part in the study.  
{y" ond yide effeca rclaed to a course of accelerated po$-martectomy rrdiution thernpy (A-PMRA fuhile these dsks apply to all patients undergoing chest wall irradiation, they **y or*u, more (or less) li'equently with tle accelerated course of radiation)
Likely efficts These side effeck oocur in patiens receiving chest walr irradiation:
r reddeming of the skin drxing featment and for several weeks following teatrnent
. t&nning of the skin lastingmonths and may be pennanent r tiredness and weakness during treatment and for sevcral weeks following treaunent r rnuscles in chest wall under treatsd breast may lbel tight or sorc Less lifuly effias These side e{rects oucur in patienLs receiving chest wall irradiation:
o peoling of the skin in the alea treated rrith radiarion
. pain nt the .site of radiatjon tre&ilrsnt
. painless dilated blood vessels under skin called telangiectasia Rsre. but seriaus e.ffucts These sidc eff'ects are r&re bul serioue, occurring in patients receiving *,hole breast radiution therapy or chest wall irmdiatinn:
. cough . difficulty breathing
. irritation nf the sac $Jrounding the heart
. inflammation of thr.heartmuscle
. rib fraefure
. ano&er c&noer due tr: radiation therapy
' injury to the nerves carrying sensation and moveynsnt to the upper cxtremity (ann)

If you are pregnant, you cannot take part in this study. Radiation therapy, ever whctr delivered at a site away lrom tlre pregnant Bbdomedpelvis, cnn r**i,lt in rndiarion clos. io the rurbom bahy that can be heffnful &o the baby. Effects of radiation on an urborn baby cau include organ malformation and rnental retardation. Iieca,rs* oI this, 1,ou should not become pregna$t if you decide to take part in this study.  
{ yg" are currently breast lbeding a chil,d and agree to partioipate in this slutly, you must stop brea,st feeding before receiving ths lirst dose of radiation. You rnust agree to discouiinrrc breast feeaing tbr the entire tirne you are partioipating in the study to prevent any potential health risk or iryury t, tt.  
child.. Although the breast milk will novcr transrnit iodiation tn your baby, the tcxturc an4 quality of the milk may change due to changes in the brenst from the ra{iation. 'Ask your doctor fbr more intbnnltion ff yr:u are capable of becoming pregnaot, & prcgnancy trst (using a urinc andlor blootl sample) will he done and thE results must be negalive hefore ,ou axc peinriuetl to enroll in this study. i rcpeat prsgnancy test must be done iliyou miss any pcriods or your menstrual cyclc bccomes irregular.  
-
If you have not gone thmugh menopauss, tve can prnvide you with more information about prevcnting pregtancy. .  
For more inti:rmation about risks and sidc cflbcts, ask your stucly doctor-

!tt$ryIgkln-spart.inthisstudv.You."n*il;rn.,,,onoi"nirrir*",ff You will gei medical lreatment if you arc injured as a resull of takingparl. in this study. You and/or your health plan will be respunsible l'or the costs ol'this treatorent.
Clinical trial: NCT01417286
Section: Procedures
Subsections: What Will Hrppen If I Take Part In This Rcsenrch Study?

[le.fiire you be.gin the shdy: Before you are on the study, you will have your masteolorny. ln ordcr to rugister tbr the study, the tbllovr{ng exarn:rt tests, tnd procedures must show that ynu are eligible
(quali$ to be in the study)" These exan$i tests, and procedures are part ofregulnr canc&r care aud r.l'i I 0 i{i14 ffi
**---ffiPrffifrffie\#;ro i\$)prlsvffitr maybe done even if yol do lotioin this study. If you havchud some 01'them recer*ly, they may not nesd to he rrpeatcd. This will bo up b your study doctor. If you nced chemotherapy and your rnedical oncologist sequenc€s that before your rfldietion therflpy, you mu$t waituntil at leasl 3 weds aller yow chemotherapy to begin y'our radiation therapy on this study. Your radiation treatment plalning, including uUtaioing a CT scan to help aim the radiation, can begin 2 weeks after your Lhemotf,".upy ood". you miry receive chernotherapy before your mastectonry and still he eligiblo tbr the study.  
o history nadphYsicalexanr r chest x-ray or chsst CT $can r breastexum r C'l' scan of the breast firat had the cancer to help pla:r tle radiation therapy r blood tests (including a pregnancy test for wnrnen of childbearing potentid)"
Iluring the study: If the exams, tcsts, and procedures show that ,You cen be in the study, and you choose to take part, you nrust sign the infiormecl consent lbrm. At this time you arc regi.stercd on the sh.ldy and yx will 01en undergcr rariiationtrcatment planning (CT Simulation).  
you will receiye 11 radiation treatrnents that are dircstcd at the chest wall and possibly ftased on yoq,: ,*"ol.rgists discretion) at *1s draining lfrrph nodes under tlte arm, under the breast bone, and arountl the ci[ar bone. Soinetimes docto.r tr*at tlre srea around the ma$eclc]my scar wit]r a higher dose of radiation, re(brred to as a "boost" or a "scar trxrst" and your physioian llray c]roose m do this.  
F.OR ALL PATIENTS: Il.arliation does not stay in your bod,v betr.een treatments or after the final trealment.  
R adiation Treatm ert Sshedules If you do not need chemothertpy or {your chemotherapy w*s delivered before the m.ostectotny
. you must wait at least 2 rveeks after your rnaste.ctomy to register fbr the study and for radiation trcatrneut plnnning (C' I Sinruiatiou).  
. Tbree weeks from your mastectomy is the earliast that you can stint your radiation trefltments,
. A-pMRT treatments are once daily fnr I I eonsecutive weekdays. Each daily treatment of A'
PMR.T lasts arotmd 10"- 15 minutss.  
. Your treating doctor may choose to add ar optional "boost" trcatmenl to the soal' arca. A
maximum of 4 additional treatmcnl$ may be giveir on consecutive u'eckdays. Each treatmcnt will la.st 10-15 minutes.
If you need chemotherapyt Yorr medicai oucologist will $equence yow chemothffapy sither befr:re jr-afte. radiation treatrucnts. "llre most import:mt nile for this eategory is that you mllst urait at lcast 3 1veeks between chemotherapy ancl rariintion therapy (or radiation therapy and chemotherapy).
Clinical trial: NCT01417286
Section: Withdrawal from Study
Subsections: Can I Stop Bdng In The Study?

Yes, yott can decidc to stop at any time. Tell the shrdy dnekn illyuu arc thinkiug about stopping or decide to stclp. lle or she will tell you how to stop safrly.  
It is important to tell the study doctor if you are thinking about stopping so eny risks from the study heatment can be evaluated by your doolor. Anottrer reason to tell your doctor ffrat you are thinking alxrut stopping is to diwu,ss what lbllow-up carc and testing could be most hclpfirl for you.  
If you change your mind, you nflust revoke your spproval in a written rcquest to Dr, "Atif Klraqgl lhe addreeq on the fir8t page of llqs^-cmtgl$. Beginning on the date you revoke y'our approval, no new personal health information will be used far researott. However, researchers rnay continue to use thc hcalth information that rvas prervided hsfore you r.rirhdrclry your approval.  
You can choo,se to *'ithdraw in one of two u,ays. In the first, you cnu stop your study treatment hut still allol the srudy doctor to fbllow your care. In the secoud, you can stop your study rrsatment anrI
not havs any further contact with the study staff.  
Can anyonr else stop me frorn being in t}e study?  
"l'hc study doctor may stop you Irorn taking part in this study rit a.ny lime if hc or $hc believes it is in the best interest for your heajth, if you do not lbllow the stucly rules, or if tlic stucly is stopperl by CINJ.