Triple Negative Breast CancerPhase 1/2NCT02734290

Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer

A Phase 1/2 study testing Pembrolizumab, Paclitaxel and Capecitabine in people with Triple Negative Breast Cancer, run by Providence Health & Services at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The goal of this study is to establish the safety and tolerability of pembrolizumab when administered in combination with either of two chemotherapy regimens (weekly paclitaxel or capecitabine) in unresectable/metastatic triple negative breast cancer (MTNBC) patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Triple Negative Breast Cancer
What is being tested?: Pembrolizumab, Paclitaxel and Capecitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 2 sitesUnited States
Study dates: 23 Feb 2016to Dec 2026
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be willing and able to provide written informed consent/assent for the trial.
Be 18 years of age on day of signing informed consent.
HER2-negative breast cancer (defined by immunohistochemistry (IHC) 0-1 (or) IHC 2 and in situ hybridization (ISH) HER2 / centromere on chromosome 17 (CEP17) < 2.0);
ER and PR-negative breast cancer (defined by IHC<1%);
Measurable metastatic or unresectable disease based on response evaluation criteria in solid tumours (RECIST) 1.1.
Indicated for treatment with either weekly paclitaxel or oral capecitabine, as first or second-line chemotherapy in the metastatic/unresectable setting (as determined by the consenting investigator);

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Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained during screening. Archival tissue is acceptable if no intervening anti-neoplastic therapy has been administered, and if sufficient material is available for analysis (see section 8.0 for requirements);
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Demonstrate adequate organ function as defined by protocol defined lab values
Female subjects of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment.

Who cannot join

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Has a known history of active TB (Bacillus Tuberculosis)
Hypersensitivity to pembrolizumab or any of its excipients.
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study, Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. Denosumab is allowed.
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy and alopecia are an exception to this criterion and may qualify for the study.

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Has received the assigned chemotherapy regimen previously in the metastatic setting, or has received the assigned chemotherapy regimen previously in the (neo)adjuvant setting within 12 months of consent;
If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Has a known additional malignancy that progressed or required active treatment in the last 5 years.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Has history of/active pneumonitis requiring treatment with steroids or history of/active interstitial lung disease.
Has an active infection requiring systemic therapy.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
Has received prior therapy with an anti-programmed death 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1), or anti-programmed death ligand 2 (anti-PD-L2) agent or has participated in a Merck-sponsored pembrolizumab study.
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Has known active Hepatitis B or Hepatitis C.
Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Cedars-Sinai Medical Center
Los Angeles, California, 90048
Providence Cancer Center
Portland, Oregon, 97213

Other trials in United States

About this study

Official title: A Pilot and Phase II Study to Assess the Safety, Tolerability and Efficacy of Pembrolizumab Plus Chemotherapy in Metastatic Triple Negative Breast Cancer Patients

Read the detailed description

In the pilot phase, patients will be enrolled to one of two experimental arms, which will be selected by the treating investigator (arm A: pembrolizumab + weekly paclitaxel; arm B: pembrolizumab + capecitabine).

Subjects will receive pembrolizumab via intravenous (IV) infusion at 200mg every three weeks (Q3W), and continue treatment Q3W until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur, up to 24 months.

Paclitaxel will be administered intervenously on a weekly schedule at a dose of 80mg/m2.

Oral capecitabine will be administered at total daily dose of 4,000 mg (2,000 mg two times each day (abbreviated BID)). Capecitabine will be administered as intermittent therapy given on days 1-7 in 14-day cycles.

Conditions: Triple Negative Breast Cancer
Being tested: Pembrolizumab, Paclitaxel, Capecitabine
Keywords: metastatic, Human epidermal growth factor receptor 2 (HER2) negative breast cancer, Estrogen Receptor (ER) negative breast cancer, Progesterone Receptor (PR) negative breast cancer, Immunotherapy, Breast Cancer
Medical subject headings: Triple Negative Breast Neoplasms, Neoplasm Metastasis, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PembrolizumabDrug
Also called Keytruda
Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
PaclitaxelDrug
Also called Taxol
Paclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle
CapecitabineDrug
Also called Xeloda
Capecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.

Study groups in NCT02734290
Study group	Role	What they receive
Arm A	Experimental	pembrolizumab + weekly paclitaxel Receives: Drug: Pembrolizumab; Drug: Paclitaxel
Arm B	Experimental	pembrolizumab + capecitabine Receives: Drug: Pembrolizumab; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment-Associated Adverse Events Requiring Discontinuation
The count of participants who experienced serious adverse events and grade III/IV treatment-associated adverse events requiring discontinuation of pembrolizumab.
Measured: 6 weeks
Number of Patients Who Complete Chemotherapy Without a Dose Delay of More Than 21 Days.
The number of patients who complete 6 weeks of chemotherapy without requiring a dose delay of more than 21 days.
Measured: 6 weeks

Secondary outcomes (1)

Overall Response Rate
Patients will have a computerized tomography (CT) scan (preferred) or magnetic resonance imaging (MRI) scan at 12 weeks to measure the size of target lesions. The percentage of patients whose tumors respond to treatment at 12 weeks will be compared to historical controls. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 2016Dec 2026

First posted12 Apr 2016 (estimated)
Study start23 Feb 2016
Primary completion21 Aug 2019
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02734290
Sponsor's protocol ID: 16-001
Status last verified: Apr 2026
First submitted: 28 Mar 2016
Last updated: 24 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Page DB, Pucilowska J, Chun B, Kim I, Sanchez K, Moxon N, Mellinger S, Wu Y, Koguchi Y, Conrad V, Redmond WL, Martel M, Sun Z, Campbell MB, Conlin A, Acheson A, Basho R, McAndrew P, El-Masry M, Park D, Bennetts L, Seitz RS, Nielsen TJ, McGregor K, Rajamanickam V, Bernard B, Urba WJ, McArthur HL. A phase Ib trial of pembrolizumab plus paclitaxel or flat-dose capecitabine in 1st/2nd line metastatic triple-negative breast cancer. NPJ Breast Cancer. 2023 Jun 21;9(1):53. doi: 10.1038/s41523-023-00541-2.
PubMed 37344474
Chun B, Pucilowska J, Chang S, Kim I, Nikitin B, Koguchi Y, Redmond WL, Bernard B, Rajamanickam V, Polaske N, Fields PA, Conrad V, Schmidt M, Urba WJ, Conlin AK, McArthur HL, Page DB. Changes in T-cell subsets and clonal repertoire during chemoimmunotherapy with pembrolizumab and paclitaxel or capecitabine for metastatic triple-negative breast cancer. J Immunother Cancer. 2022 Jan;10(1):e004033. doi: 10.1136/jitc-2021-004033.
PubMed 35086949

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot and Phase II Study to Assess the Safety, Tolerability and Efficacy of Pembrolizumab Plus Chemotherapy in Metastatic Triple Negative Breast Cancer Patients
ClinicalTrials.gov ID: NCT02734290
Acronym / sponsor ID: 16-001
Conditions: Triple Negative Breast Cancer
Keywords: metastatic, Human epidermal growth factor receptor 2 (HER2) negative breast cancer, Estrogen Receptor (ER) negative breast cancer, Progesterone Receptor (PR) negative breast cancer, Immunotherapy, Breast Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 29 participants (actual)
Lead sponsor: Providence Health & ServicesUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 23 Feb 2016 (actual)
Primary completion: 21 Aug 2019 (actual)
Study completion: Dec 2026 (estimated)
First posted: 12 Apr 2016 (estimated)
Results: Posted 22 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Paclitaxel will be administered intervenously on a weekly schedule at a dose of 80mg/m2.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A	Experimental	Drug: Pembrolizumab, Drug: Paclitaxelpembrolizumab + weekly paclitaxel
Arm B	Experimental	Drug: Pembrolizumab, Drug: Capecitabinepembrolizumab + capecitabine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Be willing and able to provide written informed consent/assent for the trial.
Be 18 years of age on day of signing informed consent.
HER2-negative breast cancer (defined by immunohistochemistry (IHC) 0-1 (or) IHC 2 and in situ hybridization (ISH) HER2 / centromere on chromosome 17 (CEP17) < 2.0);
ER and PR-negative breast cancer (defined by IHC<1%);
Measurable metastatic or unresectable disease based on response evaluation criteria in solid tumours (RECIST) 1.1.

Key exclusion criteria (20 listed)

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Has a known history of active TB (Bacillus Tuberculosis)
Hypersensitivity to pembrolizumab or any of its excipients.
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study, Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. Denosumab is allowed.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PembrolizumabAlso: KeytrudaPembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle	Drug	Arm A, Arm B
PaclitaxelAlso: TaxolPaclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle	Drug	Arm A
CapecitabineAlso: XelodaCapecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.	Drug	Arm B

Primary outcome

Treatment-Associated Adverse Events Requiring Discontinuation
Time frame: 6 weeks
The count of participants who experienced serious adverse events and grade III/IV treatment-associated adverse events requiring discontinuation of pembrolizumab.
Number of Patients Who Complete Chemotherapy Without a Dose Delay of More Than 21 Days.
Time frame: 6 weeks
The number of patients who complete 6 weeks of chemotherapy without requiring a dose delay of more than 21 days.

1 secondary outcome

Overall Response Rate
Time frame: 12 weeks

Results and safety

Results posted to the registry on 22 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A (Paclitaxel)	15	13
Arm B (Capecitabine)	14	14

Primary outcome: Treatment-Associated Adverse Events Requiring Discontinuation

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Arm A (Paclitaxel) n = 15	Arm B (Capecitabine) n = 14
Discontinued Patients	2	0
Continued Treatment	13	14

Primary outcome: Number of Patients Who Complete Chemotherapy Without a Dose Delay of More Than 21 Days.

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Arm A (Paclitaxel) n = 15	Arm B (Capecitabine) n = 14
Patients Completed Chemotherapy	15	12
Patients Requiring Dose Delay of More Than 21 Days	0	2

1 secondary outcome is reported in the full results.

Adverse events

Time frame: ~21 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A (Paclitaxel)	5 of 15 (33.3%)	15 of 15 (100%)	1 of 15
Arm B (Capecitabine)	4 of 14 (28.6%)	14 of 14 (100%)	1 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37344474Page DB, Pucilowska J, Chun B, Kim I, Sanchez K, Moxon N, Mellinger S, Wu Y, Koguchi Y, Conrad V, Redmond WL, Martel M, Sun Z, Campbell MB, Conlin A, Acheson A, Basho R, McAndrew P, El-Masry M, Park D, Bennetts L, Seitz RS, Nielsen TJ, McGregor K, Rajamanickam V, Bernard B, Urba WJ, McArthur HL. A phase Ib trial of pembrolizumab plus paclitaxel or flat-dose capecitabine in 1st/2nd line metastatic triple-negative breast cancer. NPJ Breast Cancer. 2023 Jun 21;9(1):53. doi: 10.1038/s41523-023-00541-2.
Derived from this study: PubMed 35086949Chun B, Pucilowska J, Chang S, Kim I, Nikitin B, Koguchi Y, Redmond WL, Bernard B, Rajamanickam V, Polaske N, Fields PA, Conrad V, Schmidt M, Urba WJ, Conlin AK, McArthur HL, Page DB. Changes in T-cell subsets and clonal repertoire during chemoimmunotherapy with pembrolizumab and paclitaxel or capecitabine for metastatic triple-negative breast cancer. J Immunother Cancer. 2022 Jan;10(1):e004033. doi: 10.1136/jitc-2021-004033.
Providence Cancer CenterLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Page, MD principal investigator

Medical Oncologist

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pembrolizumab, Paclitaxel and Capecitabine in people with Triple Negative Breast Cancer, run by Providence Health & Services at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-Associated Adverse Events Requiring Discontinuation (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02734290, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.