Cisplatin vs Paclitaxel for Triple Neg

Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:February 2014
End Date:June 2021

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A Randomized Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Patients With Triple Negative Breast Cancer: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker

This research study is evaluating how well triple negative breast cancer responds to
preoperative treatment with Cisplatin or Paclitaxel chemotherapy, and if use of a research
test Homologous Recombination Deficiency (HRD) assay can predict response to preoperative

Before the research starts (screening, the participant will be asked to undergo some
screening tests or procedures to find out if the participant can be in the research study.
Many of these tests and procedures are likely to be part of regular cancer care and may be
done even if it turns out that the participant does not take part in the research study. If
the participant has had some of these tests or procedures recently, they may or may not have
to be repeated.

Additional research procedures to be performed at the time of screening:

A research tumor biopsy will be taken before the participant beginning study treatment. This
is different from the first biopsy done to establish the diagnosis of breast cancer. A
research biopsy is required to participate in this research study because the research done
on the tumor tissue is a very important part of this research study. The researchers want to
learn why some cancers shrink with this study treatment while others do not.

Tumor tissue will be collected again for research either during the participant's subsequent
breast surgery, or, if the tumor has not responded well to the end of study treatment, by a
tumor biopsy before the participant is changed to another regimen.

- A small clip may be placed in the tumor bed at the time of the first research biopsy,
particularly if one was not placed at the time of the participant's diagnostic biopsy.
The clip is placed so that the surgeon can locate the site of the tumor at the time of
surgery. This is considered a standard of care procedure for breast cancer. The research
biopsy is done in an outpatient setting using a local anesthetic.

- If the participant takes part in the study, the investigators will collect a piece of
the participant's tumor tissue from their original biopsy and, if there is any tumor
remaining at the time of the final surgery, a piece of that as well. As described above,
the participant will undergo a breast biopsy and tumor tissue will be collected from
that procedure. All of this tissue will be used for research. The research on the
participant's sample may include looking at genes (DNA), proteins, or the substances
that make proteins (called RNA) in the tissue sample. Collectively, this research is
called biomarker research and may help doctors to better understand the disease, how the
drug is working in the participant's body, and may help to identify which breast cancers
may benefit most from treatment with cisplatin or paclitaxel. Specifically, the
researchers will measure the HRD assay by analyzing the tumor tissue, and determine if
the results of this assay help predict whether the cancer will respond to the
preoperative chemotherapy received. As the researchers do not know whether the results
of this test will be predictive, the participant will not receive the results from this
research test.

The tissue samples will be given the same code as the participant's other study information
and kept in locked storage. The tests on the participant's tumor tissue are for research
purposes only and would not be done if the participant were not in this study; this is
biomarker research.

- These tests will be performed at laboratories that may be within or outside of the study
center where the participant receive the study drug. The samples will be coded with a
unique number. The participant's name or other personal information will not be given to
these laboratories, and only the study doctor will be able to identify the participant
by this number. This research biopsy is not optional and may be stored for future

- The participant will have 2 additional tubes of blood collected for research purposes.
These research blood samples may be collected at any time during the course of this
research study. The blood that is being collected so researchers can look at the
participant's DNA. It is important to have the DNA in order to compare it to the DNA in
the participant's tumor. The investigators will also be performing genetic testing on
one of the blood samples, looking for gene mutations which may increase risk of
developing certain types of cancers. The blood may also be used for future research
studies. The blood will be stored by the study sponsor or its authorized agents until it
has been exhausted. This research blood collection is not optional and may be stored for
future research.

The participant will be "randomized" to receive either Cisplatin or Paclitaxel chemotherapy
prior to removal of their breast cancer. Chemotherapy administered before removal of the
cancer is known as preoperative chemotherapy.

Study Drugs:

- Cisplatin: If the participant is randomized to receive Cisplatin, the participant will
receive Cisplatin once every 3 weeks for a total of 4 doses. Note, doses can also be
referred to as cycles. The participant will be given Cisplatin by vein (IV). The
Cisplatin infusion can take approximately 1 hour. Before and after receiving Cisplatin,
the participant will receive fluid hydration by vein, and the participant will also be
given medicine to help prevent side effects such as nausea. The total time of the
infusion of Cisplatin and the additional fluid and medications will take approximately 6

- Paclitaxel: If the participant is randomized to receive Paclitaxel, the participant will
receive Paclitaxel once a week for 12 weeks for a total of 12 doses. The participant
will be given Paclitaxel by vein. The Paclitaxel infusion can take approximately 1 hour.

- The study treatment will be stopped if the participant has serious side effects or if
the tumor grows despite receiving Cisplatin or Paclitaxel chemotherapy. The
participant's doctor will then discuss with the participant alternative treatment

- Physical exams: Every 3 weeks, and approximately 2-4 weeks after the last chemotherapy
dose, the participant will have a physical exam (including weight and vital signs, as
well as tumor measurements) and the participant will be asked general questions about
their health and any medications the participant may be taking, as well as specific
questions about any side effects the participant may be experiencing while receiving
study treatment.

- Blood tests: Prior to each cycle of chemotherapy, the participant will have standard
blood tests to check their blood counts. About 1 tablespoon of blood will be drawn for
these tests.

- Surgery to Remove Tumor: This will occur within six weeks after the last dose of
chemotherapy (either Cisplatin or Paclitaxel). The participant and their surgeon will
decide on the type of surgery (i.e. lumpectomy or mastectomy) as the participant would
as part of standard care for their disease.

- After receiving the total course of Cisplatin or Paclitaxel chemotherapy, if the
response in the breast cancer is not adequate before surgery, there is the option to
receive additional chemotherapy outside of the trial prior to surgery. This is a
decision the participant can make with their treating physicians. If it is determined
that additional chemotherapy is needed, a second biopsy of the tumor tissue will be
performed before the next chemotherapy is started.

- Tumor assessments: The treating physician or nurse practitioner will examine the
participant every 3 weeks. A measurement of their tumor will be performed as part of
their physical exam.

When the tumor is removed, a research sample will be obtained from the hospital and used to
confirm the participant's response to the chemotherapy that the participant has received. It
will also be used to see if the investigators can learn which breast cancers are likely to
respond to either Cisplatin or Paclitaxel. Tumor specimens from the initial breast cancer
biopsy and from surgery after chemotherapy will be sent to the study pathologist so that the
response of the tumor to the study treatment can be assessed. After these tumor specimens are
reviewed, they will be returned to the hospital at which the biopsy and surgery were

Inclusion Criteria:

- Participants must meet the following criteria on screening examination to be eligible
to participate in the study

- Pathologic documentation of invasive breast cancer by biopsy (FNA alone is not

- AJCC clinical stage I with T1 > 1.5 cm, stage II or III invasive breast cancer.

- Participants with multicentric or bilateral disease are eligible if at least one
lesion meets stage eligibility criteria for the study and no tumor is HER2-positive.
In this circumstance, the investigator must determine which will represent the target
lesion to be assessed for response. This should remain consistent throughout the
study. The target lesion should be selected on the basis of its size (lesion with the
longest diameter) and suitability for accurate repetitive measurements.

- Tumors must be HER2 negative defined as HER2 0 or 1+ by immunohistochemistry (IHC)
assays and /or lack of gene amplification by FISH defined as a ratio < 2 on invasive
tumor by local review.

- ER and PgR status by IHC must be known. Tumor must be ER and PR negative (≤5%
staining) by local review.

- Known BRCA1/2 status is not required for study entry. However patients known to have a
germline deleterious BRCA1/2 mutation should be encouraged to consider a preoperative
trial specifically designed for BRCA1/2 carriers, if available.

- Breast imaging should include imaging of the ipsilateral axilla. For subjects with a
clinically positive axilla, a needle aspiration, core biopsy or SLN procedure will be
performed to confirm the presence of metastatic disease in the lymph nodes. For
patients with a clinically negative axilla, baseline assessment of the axilla will be
performed at the discretion of the treating investigator. For patients with
pathologically positive axillary lymph nodes prior to preoperative therapy, a level I
and II lymph node dissection at the time of definitive surgery is recommended.

- Participants with axillary adenopathy only are not eligible for this study.

- Patients with a prior history of contra-lateral breast cancer are eligible if they
have no evidence of recurrence of their initial primary breast cancer within the last
5 years.

- Women ≥ 18 years of age.

- ECOG performance status ≤1 (see Appendix A).

Laboratory Evaluation

- Absolute neutrophil count (ANC) ≥ 1,500 / mm3

- Platelet count ≥ 100,000/ mm3

- Bilirubin ≤ 1.5x upper limit of normal (ULN), for patients with Gilbert syndrome,
direct bilirubin will be measured instead of total bilirubin ALT, AST ≤3.0 x ULN ALK
Phos <2.5 x ULN

- Creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 cc/min

- Hemoglobin ≥ 9 mg/dl

- Use of an effective means of contraception is required in subjects of childbearing
potential since study agents are known to be teratogenic. Should a woman become
pregnant or suspect she is pregnant while participating in this study, she should
inform her treating physician immediately. Women of child-bearing potential and men
must agree to use adequate contraception (barrier method of birth control; abstinence)
prior to study entry and for the duration of study participation.

- Ability to understand and the willingness to sign a written informed consent document

- Individuals with a history of other malignancies are eligible if they have been
disease-free for at least 5 years and are deemed by the investigator to be at low risk
for recurrence of that malignancy and did not receive prior chemotherapy. Individuals
with the following cancers are eligible if diagnosed and treated within the past 5
years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.

- Patient must be willing to undergo mandatory research biopsy and blood draw. Prior to
biopsy procedures patients must be able to be off medications that could increase the
risk of bleeding

Exclusion Criteria:

- Prior chemotherapy: Prior non-taxane or platinum containing chemotherapy will be
allowed if the prior exposure was at least 5 years ago and the exposure is thought not
to potentially interact with the primary outcome of the trial or put the patient at
undue risk, and should be reviewed with study PI on a case by case basis.

- Any prior treatment for the current breast cancer, including chemotherapy, hormonal
therapy, radiation or experimental therapy.

- Ipsilateral breast recurrence, unless prior treatment consisted of excision alone for
DCIS or breast conserving treatment and hormonal therapy for DCIS or invasive breast

- Ongoing use of any other investigational or study agents.

- Peripheral neuropathy of any etiology > grade 1 (NCI CTCAE Version 4.0- Appendix B)

- Significant hearing loss that would prevent cisplatin administration.

- Renal dysfunction for which exposure to cisplatin would be unsafe or require cisplatin
dose modification (i.e., Cre > 1.5 mg/dl or GFR < 60 cc/min).
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