Cisplatin vs Paclitaxel for Triple Neg BRCA
Brief description of study
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
Clinical Study Identifier: NCT01982448
Detailed Study Description
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
- 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
- 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.
- 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 hours.
- 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
- 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
- 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