Clinical trial: NCT02315196
Section: Alternatives
Subsections: Con You Tcke Othsr Medisines While Ou This Rtudy?|Lvhst Sr€ Your Nlternatives If You Don'T Wsnt To Take Pert In Tkir Study?

You should not take any cver-the-counter mediches, berbal products, vit*mins or foodstrpplements while taking part h this shrdy" unless you tell the shrdy doctor and get pennission from the shrdy doctor to go on taking these rnedicines. You will follow the instnrctions of the shrdy doctor about the use of any of these products.  
You should also tell the study doctor about all niedicines that other doctors may have prescribed for yorr to take.  
Are tbere uny benelits for you if you choose to take part in thi* research study?  
There may or may not be direet medical benefit to you &om takiug part fu] tbis shrdy. If the treahnent is successfirl, it is hoped tlrat yowbreast cancer will becoure smaller in size or disappear, reduciug tlre risk of your breast cancer coming back in the firhue. It is hoped that the iufonnatiou lenrned froru this study will also benefit other patients with breast cancer in tlre fuftue. However. it is possible that iufomratiou lear:red &om yoru particular breast cancer rnay be helpful to yoru care inthe future.

The following altenrative treatnrents are available if you choose not to take have beeu given fhe chance to ask questiorrs about theu:
part in this study. and you  
o You may choose not to reeeil'e tlre medication designated in this sttdy e You nray receive non-eKperiurental keatnrents and can ask the treafineuts.  
r You may choose to participate in an altemative experinrental treatureut urd cao ask yorx shrdy doctor about other treatment studies thrt arc available.  
to treat yorr breast cancer.  
study doctor about these
Talk to your doctor about your choices before you decide if you r,vill take part i* this study. You are rruder no obligatiou to take part in this research study. If you decide fhat you do not wish to take part in this shrdy, you are free to leave the study at any time.  
How will you krow if new informrtion is lcrrnsd t&rt may affect whether you are willing to stry in this research rtudy?  
During the coruse of the study, you will be trpdated abouf auyuew intbnnatiol that uray affect whether you are rvilling to go ou taking parl in the shrdy. If uew infonuation is learned that may affect you after the shrdy or yorr follorv-up is completed, you will be contacted.  
Will there be any cost to you to take p*rt in this study?  
You and/or you instuance company will be billed for the costs of yCIul treatnerrt thet are cousidered staadard of care (for example, doctor/ Advanced Praetice Nruse (APN) visits, musing care to admirdster the keatrnents, routiue lab tests, restagiug scails. etc.) as you would have received these services even if StrrdyTitlc:C*.o*i"F@stca$ccrinaclirdcaltriallr.ithfiurctionalclraractcrizaticrrofrcsistarrtdiscase Principal luvcrtigotor:
you were not participating in this study. You will be responsible for arry co-papnetrts due for offtce visits, co-insruances aud deductibles due on any tests andlor procedures that are requir"ed urd considered standard care.  
Carboplatin, liposomal doxonrbicin, paclitaxel, aud epinrbicin are all courmercially available drtgs. You or your insruance co&rparly will be bitled for the cost of these medications.  
If you have any questious aboui inswance correrage, irrcluding auy out of pocket expeuses youmight incur, or which laboratory or facilities you are allorved to have tests at, a fiuancial coturselor rvill be made available to you upon reqtrest.  
Optiorral andor research r*lat collecfion and blood samples will be paid for
Clinical trial: NCT02315196
Section: Duration of Study Involvement
Subsections: Lilhen Will Your Ruthoriestion Expire?

There is no set date at which your authorization rvill expire. This is because the informction rced and ereated dtring the str:dy may be analyzedfor uxury years, and it is not possible to know when this will be
Clinical trial: NCT02315196
Section: Participant's Rights
Subsections: Lvho May Take Ptrt Iu This Rtutly? And Who May Not?

You may be included iu this study ifl r You have been diaguosed with stage II-III breast carlcer that does uotexpress estrogen receptor, progesterone receptor. or HER2 proteir.  
t You are at least l8 years ofage.  
You are uot preprant.  
You have an adequate contacepfive urefhod during teatrnent and fol three rnonths aller completirg heahnefi.  
You have a suffrcient level of daily activrty.  
You meet specific criteria on bloodwork for blood counts, kielney, and liver firnction.  
You have adequate lrcart fi.ruction.  
You have had imaging to exclude metastatic (the spread of cancer from the place where it sta*ed to other places in the body) breast cancer, i.e. breast caacer in other organs.  
You are not receiviug other trea&ests for your breast caocer.  
You have sigrred consent for this study.  
You are eligible to rurdergo stugery, either luupectoruy ((the spread of cancer fi"om the place where it started to ofher places in the body),
or mastectonry (surgery tn remove parlor all of the breast. There are differeut types of urastectomy that differ in the amount of tissue and lyrqph nodes removed) for local treatrnent of the breast cancer.  
Your cancer tissue is provided for laboratory aualysis.  
a a t e a a o I I
You may Not be included in this sfudy if:
r You are prelrrert or lrreastfeeding. r Have auother cancer except specific lirnited caucers or ot[er cil]cers treated at least 5 years previoruly with no evidence of recrureuce.  
r Have evideuce of metastatic disease. r Have a diaguosis of inflammatory breast cancer.  
r Have a history of hyperserxitivity reaction attributed to the drugs used in this study, i.e.  
doxorubicin, paclitaxel, or carboplatin.  
r Have another serious rnedical disorder that would compromise your safety CIr your ability to cor4plete the shrdy.  
r Have had a heart attack or uustable argina in the past 6 xronths, significant hearl failure, uncontrolled abnorrnal heart rhythns, strnrctursl heart disease causing significant heart dysfrrnction or sierrificant EKG abnormality.  
r Have had prior treatrnent rvith the study drugs for *ny cancer.  
r Have known or active hepatitis B or C with abuonnal liver frrnctiou tests.  
e Hove significant vasculal disease. r Have evidence of bleeding or clotting disorder. r Have lung disease resulting in moderate to severe breethiug difficulty' r Have history of a urajor organ transplant requiring c.hronic imruunosuppressio& e.9., kiduey.  
liver, lurg, heart, boue marrow traasplant. or autoimrntme diseases. Patieuts who have rcceived comeal traruplants, cadaver skin, or bone trausplants ar"e eligible.  
r Have moderate/siguificaut nervous sysfelu disorder.  
r Have a condition that would prohibit a&uinistratiou of steroids' The shrdy doctor and/or research team will also ask you other questions about your medical history in order to make sue you qualify to be in this study" IIow long will the study tsks and how mnny subjerts will partieipnte?  
A total of 60 subiects will be enrolled study wide. Approximately 60 subjects will take part in this study frorrrthe.Weexpectaccntaloverforrryear.sbrrtParticipa[tswillbe evahrated r euollntelt.  
What will you be trked to tlo if you t*ke part in thi* resrarch sfudy?  
Before you may take pm1 irr this study, yotr will ueed to Boswer questions and have the following tests and examinations to see if you are eligible" This is called scteeuiug. It is inrporl*nt to answer all questions honestly and contpletely. If anythirrg charges before or during fhe study, you rnust tell the sfudy doctor. Depending on the {u}swers to these questions and the resu}fs of the tests and exarnination. it is possible that you uray not be able to take pafi in this studyln some instances. certain tests or procedures conducted during the study nray have to be repeated. This can happeu if some or all of fhe results or tiss*e are unusable. Also, yournay be asked to have additional tests or exaruiuations. T[is cau happen if et unexpecied medical event occurs during the shrdy. Before you begin treahuent. you will need to have the following tests and procedures doae:
o A prior biopsy confimring yoru' diaErosis of breast c€ulcer and that it does not express three pr-oteius: *rt og"o receptor, progesteroue receptor, and HER2. Tltis tissue will also be used for laboratory testing to eruluate DNAJgenetic changes and expression of tissue carcer urafkem.  
r A new biopsy for rcsearch puposes r A blood specimen for research purposes r Signedcousent r Completiug a Quality of Life questionnaire at tbree cornpleted in five urinutes tirue poiuts duilrg treaturent tlrat can be A rnedical 1istory and physical exam will be done by tlre study doctor prior to starting the study and prior to each cycle druing the study.  
In addition, you will be reqtired to have:
r Blood {ests done before keatment and before each cycle dtriug the sfirdy. You rvill have blood drawg using a small needle to clreck yoru'blood counts, yorr blood clremishy. and how yorr liver and kidneys are working.  
r a ruine test to evaluafe your ki&rey firnctiou.  
r Auswered questiols *bout the extent of your physical activity, how you are generally feeling inlbnnally and usiug a brief stuvey.  
r Scags nray be done before the sfudy aud as nece$sary for evaluation of any new symptonx' e You will also need to have au ECG {elechocardiogsam, also kuown as an "EKG"- a paialess paper fi'acing of the heart's uormal electrical *ctivity)-
e If you are able to conceive, you will have a preguarcy test within oue week of the stafi of the study. If you arepregpaut, you cannot take parl.  
r Au additional biopsy may be needed to obtairr ndequafe tissue for testing andlor placement of a clip, a small ruarker to designate the location of the breast cancer, in the breast prior to sfart of freatment.  
r If you have low nunbers of white blood cells (what helps yorr fight infection) you may be given G-CSF" G-CSF is a special typ* of protein called * growth factor. It stiruulaies boue manow to make white blood cells and is given as an iujection. Your shrdy doctor rvill tell you if you need G-CSF along r.vith study dnrg adruinistration.  
Patients participatiug in this strrdy rvill receive the tbllorving cheurotherapy prior to undergoing breast smgery. Two dnrgs, carboplatin and liposoural doxonrbicin. rvill be given together every 28 days.  
Twenty-eip{rt days is cousidered a cycle. The combin*tion of calboplatin and lilnsorual doxorubici:t will be given for four cycles. Patients will then have their breast surgery followed by 1? weekly doses of paclitaxel, another type of chemotherapy. Patients will only receive additional therapy, such as radiatiou tberapy. if detemrined to be uecessary by theirtreating physieian.  
Caucerous tissue fionr the lneast biopsy will be sent for a test that looks fur gertetic abnonnalities witlrirr the cancer cells. This is called genornic analysis. These tJpes of abnonnalities are uot the kind the parents pass to their ottspring. These are abnormalities that arise within noranl cells of the breast that then result in the breast cells beharrirg as a eancer. Some of these genetic abnormalities in the cancer cells nroy tell your doctors if any additional therapies may be usefirl in the keatment of your breast career in the future. Iir the event that festing of yoru cailcer identifies an abnonnality or mutafion that could lre inherited, that is, passed from pareuts to their children. your heating physician would be notified so thal they can discuss with you whether or uot testiug to cout-rnu the presence of an inherited genetic nrutalion is appropriate. You will be able to decide whetlter or not this testing is right for yon based ou that discussiou rvith yoru physician au\#or meeting with one of otu genetic cotuselors. J"his study does not retprire you to undergo fhat specific type of genetic testing-
Caucerous breast tissue that is removed during a procedrre is uor-rnnlly seut to the pathology depaffineut where it is processed. Pathologists typically examine tlre tissue under a microscope to confitm a diagmosis and provide infonnation to tlre treatirrg physician as to possible stage of you'breast caucer and whether specific proteius are explessed which help detenuiue treatruent recouuuendatiorrs. A portiorr of tlrc calcerous tissue that is not u*ed by the pathologist rvill be requested for evaluafiou iri the laboratory to help determine sensitivity of the caocer to various other dnrg therapies. The respoase to tbese dnrg therapies and how you do on the cliuical trial will be correlated with the genornic analysis. This will help detenrrine if there are specific geaefic alteratious in tlre breast cancer that rnake it ruore (or less) sensitive to esch ofthe drugs tested.  
What are the risks and/or discomforts you might experience if you take part in this study?  
If you participate in this study, you mustundersta*d that you take the risk of treatrnent uot being effective *gainst your cancer. The dnrgsused in this study mfly car$e all, sorue or nolle of the side effects listed. In addition, there is always the risk of developing very uuconrmoo or previously unknown side a$d doxombicin has been previously
. Paclitaxel is n standard chemotherapy given for the heatnrent o cancei: Hor,vevet, some side effects fi'ou arty chemotherapy drug mny be seriouseuough to result in hospitalizatisr a&d/or death.  
Dr,riog a CT scan, you will be exposed fo small amounts of radiation, which are equal to 3 years of exposrue &onr the air arorurd us. Therre is also a rare risk of a serious allergic reaetion to the dye used irr the test.  
When your blood is drawn, there is the possibility of developing a bnrise, bleeding or (rarely) infection at the place where yorx blood is drawn. Techniques used to draw blood will rnirimize these risks.  
f6trrn6s side effects observed with aluost any chemotherapy iuclude:
Boue marrow strpprgssion: The dnrgs used to kill cancer cells also kill some uomral trody cells, especially those that gpow rapidly (blood cells, hair, cells that line the mouth, stomach and intestines).  
Blood cells are srade in the bone nmrrorv and are responsible for fig*rting infections (white bloodcells)"
carrying oxyger (redblood cells)" and causing blood to clot (platelets). A reduction in the number of thesi btodcetls (marrcw xuppression) cau lead to an increased risk of infection. weakness, or bleeding.  
Should these effeets occlu, they cau be treated with blood products (trarsfilsion*) and antibiotics.  
Reduced rvhite blood cells may be &ieated with an injection the day after chemotherapy.  
Hair loss: This may be partial or courplete and more likely withpaclitaxel thzur the corubiuatiorr of liposomnl doxorubicin with carboplatin. Hair growth usually retruus when the &tg is stopped. Hair color will not charge, but hair is sometimes eurlier.  
Nausea. vonriting and ternporary loss of appefite: This does not usually last for ruore fhau a day after the adurinistration of cheurofherapy. Anti-nausea medicatiorr will be prescribed before and duriug treaturent with cheurotherapy.  
hregular urenstnral cvcle: Womeu nr*y experience teurporarily an irregular cycle or il uray cease permauently resulting ia an inability to conceive.  
Extravastion: A leakage or e$cape of medication &our a vein into the tissues resultiug in pain and possible tissue damage.  
Secondary leukeuda: Some patierrts ruay develop lerrkeruia or a secoud carcer.  
Blood clofs: They occur frequeutly in patieuts wittr caacer aad have occurred in patients on similar studies.  
In the past few years,liposonral doxorubicin has experieuced dnrg shorlages for which measures have beer tsken to reduce this occurence. However. should another slrcrrlage occur, epinrbicin (n dnrg with action sirnilar to liposornal doxorubicin) would be given as a substitute.  
StudyTittclG**,'i"p@stcarrccrinaclirricaltrialrr.iilriurctionqlclraractcrizatiorrofrcsistantdiscasc hi".ilol luvcstigator:
Toxicities Ohe extent to which somethfuIg is hnrmfuU associated wi& the $pecific cbemotherapies used in this shrdy are listed below:
Clinical trial: NCT02315196
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Reproductiye Risks

Females will be included in this study. If you ue pre[${lnt, you earutot participate iu this shrdy. You should Bof becorue pregaa$t or father I boby while parlicipating iu this shrdy because the drugs ir this shrdy can be associated with unknown risks that codd a{fect you or an unborn baby.  
A1l sulrjects and their sporrse$ or partners must use aa effective birtb eontrol rneflmd. Some examples of birth conhol are the following: have had a prior history of surgically-inducedsterility (i.e., rubes tied, vasectonry), avoiding any activity that could calrse youfo becorue pregurarrt (no sexual inte.rcourse), or using birth control pills, fUD, condom. or double-barrier coukaception diapluagru with spennicidal jelly, hansdenual (tlrough yoru skin) or injectable contmceptives.  
You nrust practice bir{r control during the shrdy a$d for at least six months after you receive the last dose of tlre study dnrg. Before entering the study. you and the shrdy doctor nrusf aggee on the birth control metbod you will use duriug the entire study.  
A coturselor and more iuforuatiou about preveutrng preEurancy will be made available to you if you trave auy questions.  
If you are capable 6f bsssnrirrg pregnant, a pre$mncy test {using a urine audlor blood sample) will be done aud the results urust be negative before you are penuitted to enroll in this shrdy. A repeat pregnancy test must be done if you uriss any periods or your menstrual cycle beconres irregular.  
If you are crureutly breast feeding a child and agree to participate in this shtdy, you must stop breast feeding before receiving the {irst dose of snrdy drug. You urust agree to discontinue breast feeding for the entire time you areparlicipating in the shrdy to prevent auy potential health risk or injury tothe child" lf you become pregmrt wbile in this shrdy, you urust fell the shrdy doctor as soon as possible. The study doctor will advise you of the possible risks to your unbonr child and options available to you. Because of the possible risks to an turbtxr child, the study drug will be s(opped. You may be asked to receive ruedical follow-up sen'ices for yoruself duing the preErancy aud for the baby a{ter birth. You may be StudyTitlc;Gcnoruic@stcanccrirraclioiealtrial*.ithfiurction*1c}raractcrizatiorrofrcsiltantdiscasc Principal fu vcstigrtar:
asked to provide more infomlation *botrt the pregrraucy atrd its outcome.
Clinical trial: NCT02315196
Section: Purpose of Research
Subsections: Why Is This Rtudy Being Tlone?

TIre purpose of this shrdy is to deternriue the activity and safety of a couibillation chemotherapy regimeu for ear{y stage breast cance$ that do not exp(ess e$fiogen rcceptor (A protein found inside the cells of the female reproductive tissue. some other types of tissue. aud soule cancer cells. The honnone estrogen will bind to the receptors inside the cells and may cause the cells to Srow. Also called ER), progesterone receptor (A protein forurd inside the cells of the teurale reproductive tissue, sorne other types of tissue, and some carlcer cells. The honnone progesterCIne will bind to the recepiors irxide the cells and rnay cause the cells to grow. Also called PR), or HER2 protein (A protein involved in nonnal cell parvth. It is foturd on some types of cancer cells, including breast aod ovarian. Cancer cells reuroved froru the body nray be tested for the plesenc€ of HERZ to help decide the best type of treatruent). The two dnrgs doxonrbicin aud carboplatin will be given together and then paclitaxel will be given alone. Lr addifiou, this study will detemfne if there are chauges in the DNA (deoxlt'iborrucleic acid, a self-replicating material preseut in nearly *ll living organisms as the mnin constitue*t of cluouto$olnes. It is the carrier of genetic infoirnation) of the canc.sr itself that predict which breast cflrcers will have the best respome and for r.vhiEh breast canser$ we need to identi$ other effecfive treatments. Laboratory evaluations will be done to identify poteutially effective alteuutives.  
-
Drugs used as part of otu standard of care to treal early stage lrreast carcef include doxorubicin and paclitaxel. Liposomal doxonilriciu is another formtilation of doxorubicin that is FDA approved and is part of orr national oncology- grridelines for treating ntetastatic breast carcer. Car{roplatin is FDA-approved and is part of oru national oncology guidelines for treatirrg metastatic breast cancer.  
Carboplatin is approved for treating early stage, HER?-expressing trreast caucers in combiuation with other chemotherapies.  
Liposorual doxonrbiciu and carboplatin have proven berrefit in the treatrnent of metastatic breast ctulcel'"
Their eogrbilation has been tested in a clinical trjal at the Caucer Insfitute for safety, tolembility, arrd be[efit for treatmeut of breast cancem tlraf do llot express esfiogen rcceptor, progestercue teceptor or 1IER2 protein. The combination of liposomal doxonrbicin and carboplatiu has not yet been tested for tre*tment of earty stage breast saucer. Tberefore, the goal of this shrdy is to determine the response rate of early sfage breast caucers that clo not express estrogen receplor, progesterone receptor or HER2 protein to the combination of liposoural doxorubicin and carboplatiu. All laboratory correlates are for rcsearch ptuposes only.  
Why h*ve you been asked to tske part in this study?  
You have been asked to parlicipate in fis shrdy because you have beer diagrrosed with au early sfage breast calcer that does not express eslrogen receptor, progesterone receptor or the HER2 protein for which chemotherapy is a reconunended treatrueut.
Clinical trial: NCT02315196
Section: Voluntary Participation
Subsections: Consent To Take Part In A Rese,A,Rcti $Tudy|Agreement To Participate

Titte of Stutty: A Pha*e 2 trial of liposomal doxorubicin aud carboplatin in patients with ER, PR. HER2 negative breast cancer (TNBC)
Prinripal Investigator :  
  
This consent fonu is part of au informed corxent proces$ for a research study and it will provide iufomratiou that will help you to decide whether you wish to volunteer for this research study. It will help you to understand what ihe shrdy is about and what will happeu in the comse of the shrdy.  
If you have questions at auy time druing the research study, you should feel free to ask them and should expeet to be given an$tyers that you conrpletely urderstand.  
After all of yoru questions bave beea auswered. if you still wish to take part in the study. you will bs asked to sign this in{bnned consent form.  
The study doctor (tbe principal investigator) or anoltrer menrber of the study team (an investigator) will also be asked to sign this infornned consent fonu. You will be glveu a copy of the sigrned consent fonn to keep.  
You are not giving up ary of your tegal rights by volmteering {br this research shrdy or by siping this consenl fonu" Tlre costs fftat are usually eovered inclucle thirrgs suc]r as research laboratoly tests required by the study, and the costs of collecting all of the infonuafion required by the study.  
Er$lonffis l2/ol/2014 Page I of16

I have read this eutire forur, or it has been read to me, aild I believe that I uuderstaud what has been discmsed. All of my qtrestions abont this forxr or this study have been auswered.  
I agree to take part h this sfudy.  
Subject Narne:
Subject Sigprature: Date
$ignature of Retder/Translstor If the Patient Does Not Rettl English lVell:
The person who bas sigrred above, --r does not read English well.  
You read English well and are flueut in (rrcrne af the langtage), a language that the patient understands well. You understand the content of this cousent fornr and you have hanslated for the patieut the entire content of this fonn" To the best of yotu kuowledge. the patient rurderstauds the content of this lbnn and has had au opportunity to ask questiotts regardirrg the couseut fonn and the shrdy. and these questions have been answered.  
| Readerffranslator Name :                   | Date   |
|--------------------------------------------|--------|
| ReaderlTranslator Signahue : Witness Name: |        |  
Study Titlc: Gcnornic profiling oftriplc lrgativc brcast canccr in a clisical trial rvith fiurctional charactcrization ofrcsisianf discasc Witness Sicilaftue: Date:
Signature of Investigstorllndividusl Obttining Consent:
To the best of your ability" you have explainedand discussed the full contents of the study incltrding all of the ilfonnation coutained in rhis consent form. All questious of the resealch subject and those of his&er parent or legal guardian have been accurately answered.  
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hrvestigatorlPerson Obtaining Consent:  
| Sipglature:   | Date:   |
|---------------|---------|  
Thffik you for cousidering participation ia this research.  
You have reed this ertire li:*rn, or it has been read to you" aud you believe tlrat you rmderstand what has been discussed.  
All of your questions about tbis fsnu or this sh:dy have beeu answered.  
Srrbject Narne:.  
| Sutrject Sipuahue:   | Date:   |
|----------------------|---------|  
Signature of Investigator/Indivitlual Obtaining Consent:
Investigatorfferson Obtainirrg Consent:  
Signature: Date: