Malignant Neoplasm of BreastPhase 2NIBNCT03289819
Neoadjuvant Pembrolizumab(Pbr)/Nab-Paclitaxel Followed by Pbr/Epirubicin/Cyclophosphamide in TNBC
A Phase 2 study testing Pembrolizumab, nab-paclitaxel and Epirubicin in people with Malignant Neoplasm of Breast, run by Institut fuer Frauengesundheit at 4 sites in Germany.
Trial summary
Despite its aggressiveness and high incidence, to date, no targeted therapies exist for the treatment of triple negative breast cancer (TNBC). Emerging evidence suggests a crucial role of tumor immunology on outcome for this entity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Neoplasm of Breast
- What is being tested?
- Pembrolizumab, nab-paclitaxel and Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 4 sitesGermany
- Study dates
- 23 Mar 2018to 22 Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to beginning of trial specific procedures.
- Subject must be female and aged ≥ 18 years on day of signing informed consent.
- ECOG(Eastern Cooperative Oncology Group) 0-1
- Histologically confirmed, early TNBC determined by core biopsy of breast tumor lesion. ER and PR negativity are defined as ≤ 1% of cells expressing hormonal receptors via IHC (immuno-histochemistry) analysis. HER2(human epidermal growth factor receptor 2) negativity is defined as either of the following by local laboratory assessment: In situ hybridization (ISH) non-amplified (ratio ≤ 2.2), or IHC 0 or IHC 1+.
- Measurable tumor lesion with a size of ≥ 1 cm assessed by sonography or magnetic resonance imaging (MRI) within ≤ 21 days prior to entry. In case of inflammatory disease the extent of inflammation will be measured.
- Indication for chemotherapy.
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- Multicentric and/or multifocal disease, as well as synchronous bilateral breast cancer, is eligible as long as one measurable lesion meets all inclusion criteria. The investigator has to determine which lesion will be used for tumor evaluation before initiation of treatment.
- Complete staging work up within 8 weeks prior to entry with no evidence of distant disease, including bilateral mammography, breast ultrasound, chest-X-ray (or chest CT-scan), liver ultrasound (or liver CT-scan or liver MRI) and bone scan.
- Subjects must provide a core biopsy from tumor lesion at 3 time points (before, after first phase of treatment and at surgery) for central confirmation of TNBC status and biomarker analyses.
- Adequate organ function, defined as:
- Absolute neutrophil count (ANC)≥ 1.5 x10³/μl, Hemoglobin ≥ 10.0 g/dl OR ≥ 6.2 mmol/l, Platelets ≥ 100 x10³/μl, Creatinine ≤ 1.5 x ULN OR GFR ≥ 30 ml/min, Total bilirubin ≤ 1.5 x ULN, AST (SGOT) and ALT (SGPT) ≤ 1.5 x ULN, Alkaline phosphatase ≤ 2.5 x ULN, International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN, Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN,
- Female subjects of childbearing potential must have a negative urine pregnancy test within 72 hours prior to study entry and be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Who cannot join
- Concurrent participation in a study with an investigational agent/device or within 14 days of study entry.
- Prior chemotherapy, radiation therapy or small molecule therapy for any reason.
- Previous malignant disease being disease-free for less than 3 years (except in situ carcinoma of the cervix and basal cell carcinoma of the skin).
- Pregnancy or lactation.
- Prior therapy with an anti-PD1, anti-PD L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137).
- Active infection requiring systemic therapy.
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- History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Active autoimmune disease or other diseases that requires systemic treatment with corticosteroids or immunosuppressive drugs (physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency is allowed).
- History of primary or acquired immunodeficiency (including allogenic organ transplant).
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- Known history of following infections:
- Human immunodeficiency virus (HIV)
- History of acute or chronic Hepatitis B or Hepatitis C
- Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted
- Known congestive heart failure >NYHA I (New York Heart Association) and/or coronary heart disease, angina pectoris, previous history of myocardial infarction, uncontrolled or poorly controlled arterial hypertension (e.g. blood pressure >160/90 mmHg under treatment with two or more antihypertensive drugs), rhythm disorders with clinically significant valvular heart disease.
- Preexisting motor or sensory neuropathy of a severity grade ≥ 2 by NCI CTCAE v4.0.
- Known, pathogenic BRCA (breast cancer susceptibility gene) mutation. Note: testing is not mandatory for trial participation.
- Any other condition in opinion of the investigator that would interfere with applied systemic treatment or other trial procedures.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Department of Gynecology and Obstetrics, HELIOS Hospital Berlin Buch GmbH
Berlin, 13125
Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH
Bottrop, North Rhine-Westphalia, 46236
Department of Gynecology and Obstetrics, Erlangen University Hospital
Erlangen, Bavaria, 91054
Department of Gynecology, Tübingen University Hospital
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: A Phase II One-arm Open-label Neoadjuvant Study of Pembrolizumab in Combination With Nab-paclitaxel Followed by Pembrolizumab in Combination With Epirubicin and Cyclophosphamide in Patients With Triple Negative Breast Cancer
Despite its aggressiveness and high incidence, to date, no targeted therapies exist for the treatment of triple negative breast cancer (TNBC). Emerging evidence suggests a crucial role of tumor immunology on outcome for this entity. Checkpoint inhibitors like pembrolizumab, which target immune cells within the tumor, might therefore have an important impact on therapy response and outcome in these high risk patients. We propose a phase II study exploring pathological complete response and the safety of the combination of pembrolizumab and nab-paclitaxel as well as the combination of pembrolizumab with epirubicin and cyclophosphamide in the neoadjuvant setting for women with early TNBC. After completion of this study an extension will be determined.
Read the detailed description
This is a multicenter, phase II, one-arm, open-label neoadjuvant study of pembrolizumab in combination with nab-paclitaxel followed by pembrolizumab in combination with epirubicin and cyclophosphamide (E/C) in patients with TNBC. Pathological complete response rate at the time of surgery is the primary objective of this study.
In approximately six large breast cancer centers in Germany 50 patients are planned to be enrolled. All patients will undergo state of the art staging and tumor assessments prior to study entry to assess eligibility for the present trial. Eligible and consented patients will receive 12 cycles of weekly nab-paclitaxel i.v. 125 mg/m² BSA q1w in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles pembrolizumab i.v. 200 mg q3w. After the 25th patient has started trial treatment, all further included patients will receive 1 cycle of pembrolizumab i.v. 200 mg q3w monotherapy followed by 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w. Clinical and bioptic tumor assessment will be performed after each treatment phase. Additional imaging, preferably with sonography, will be performed 6 weeks after initiation of taxane and anthracycline therapy to allow for early progress and response monitoring.
Study treatment will be applied until state of the art surgery, onset of unacceptable toxicities, progression or withdrawal of consent. A safety follow-up is planned 120 days after administration of the last dose of trial treatment.
- Conditions
- Malignant Neoplasm of Breast
- Being tested
- Pembrolizumab, nab-paclitaxel, Epirubicin, Cyclophosphamide
- Keywords
- TNBC, neoadjuvant chemotherapy, triple negative breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative 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, MK-3475
All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w. After the 25th patient has started trial treatment, all further included patients will receive 1 cycle of pembrolizumab i.v. 200 mg q3w monotherapy followed by 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w.
nab-paclitaxelDrug
Also called nano-particle albumin bound (NAB) paclitaxel, Abraxane
All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w.
EpirubicinDrug
All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w.
CyclophosphamideDrug
All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab/Nab-Paclitaxel | Experimental | This is a phase II, one-arm, open label neoadjuvant study of pembrolizumab in combination with nab-paclitaxel followed by pembrolizumab in combination with epirubicin and cyclophosphamide in patients with triple negative breast cancer.
All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w.
After the 25th patient has started trial treatment, all further included patients will receive 1 additional cycle of pembrolizumab i.v. 200 mg q3w monotherapy before starting regular trial treatment.
Clinical and bioptic tumor assessment will be performed after each treatment phase. Study treatment will be applied until state of the art surgery, onset of unacceptable toxicities, progression or withdrawal of consent. Receives: Drug: Pembrolizumab; Drug: nab-paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) rate
Pathological complete response (pCR) rate, defined as the complete absence of all tumor cells (ypT0/ypN0), absence of invasive tumor (ypT0/is ypN0) and regression grades after study treatment. Pathological complete response is the primary endpoint of this trial and correlates especially well with disease-free survival and overall survival in patients with TNBC. Pathological complete response also serves as a surrogate marker for prognosis in TNBC
Measured: Pathological complete response will be assessed at final surgery for patients who received at least two cycles of Pembrolizumab. The rate will be assessed from 30 days until 120 days after last application of medication.
Secondary outcomes (4)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The safety endpoints for the study will include rate of AE/SAEs and fatal SAEs, causality and outcome of AE/SAEs, rate of treatment discontinuations and reasons, changes in vital signs, laboratory values etc. Grading of AE/SAEs will be based on NCI CTCAE v4.0.
Measured: The adverse events will be assessed from first infusion until 120 days after last application of medication.
Clinical Response
To evaluate the efficacy of the treatment as measured by clinical response (objective response rate by 30 %) 6 weeks after the start of each sequential chemotherapy (nab-paclitaxel and E/C) and at the time of the surgery
Measured: Every 6 weeks from date of first medication administration until the date of first documented progression, surgery or date of death from any cause, whichever came first, assessed up to 120 days after last dose.
EORTC QLQ-BR23
To evaluate changes in health related quality of life (QoL) assessments from baseline in all subjects using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
Measured: Every two weeks from first administration of trial medication through study completion, up to 120 days after administration of last medication.
EORTC QLQ-C30
To evaluate changes in health related quality of life (QoL) assessments from baseline in all subjects using Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Measured: Every two weeks from first administration of trial medication through study completion, up to 120 days after administration of last medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start23 Mar 2018
- Primary completion27 Aug 2020
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of BreastStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fuer Frauengesundheit
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Peter A Fasching, MD, Prof., Study chair, Department of Gynecology and Obstetrics, Erlangen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289819
- Sponsor's protocol ID
- IFG-NIB-01
- Other IDs
- 2016-003102-14, U1111-1188-3915, 2016
- Acronym
- NIB
- Status last verified
- Apr 2021
- First submitted
- 11 Oct 2016
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II One-arm Open-label Neoadjuvant Study of Pembrolizumab in Combination With Nab-paclitaxel Followed by Pembrolizumab in Combination With Epirubicin and Cyclophosphamide in Patients With Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03289819
- Acronym / sponsor ID
- NIB / IFG-NIB-01
- Conditions
- Malignant Neoplasm of Breast
- Keywords
- TNBC, neoadjuvant chemotherapy, triple negative breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Institut fuer FrauengesundheitUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Celgene Corporation
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite its aggressiveness and high incidence, to date, no targeted therapies exist for the treatment of triple negative breast cancer (TNBC). Emerging evidence suggests a crucial role of tumor immunology on outcome for this entity. Checkpoint inhibitors like pembrolizumab, which target immune cells within the tumor, might therefore have an important impact on therapy response and outcome in these high risk patients. We propose a phase II study exploring pathological complete response and the safety of the combination of pembrolizumab and nab-paclitaxel as well as the combination of pembrolizumab with epirubicin and cyclophosphamide in the neoadjuvant setting for women with early TNBC. After completion of this study an extension will be determined.
Detailed description
This is a multicenter, phase II, one-arm, open-label neoadjuvant study of pembrolizumab in combination with nab-paclitaxel followed by pembrolizumab in combination with epirubicin and cyclophosphamide (E/C) in patients with TNBC. Pathological complete response rate at the time of surgery is the primary objective of this study.
In approximately six large breast cancer centers in Germany 50 patients are planned to be enrolled. All patients will undergo state of the art staging and tumor assessments prior to study entry to assess eligibility for the present trial. Eligible and consented patients will receive 12 cycles of weekly nab-paclitaxel i.v. 125 mg/m² BSA q1w in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles pembrolizumab i.v. 200 mg q3w. After the 25th patient has started trial treatment, all further included patients will receive 1 cycle of pembrolizumab i.v. 200 mg q3w monotherapy followed by 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w. Clinical and bioptic tumor assessment will be performed after each treatment phase. Additional imaging, preferably with sonography, will be performed 6 weeks after initiation of taxane and anthracycline therapy to allow for early progress and response monitoring.
Study treatment will be applied until state of the art surgery, onset of unacceptable toxicities, progression or withdrawal of consent. A safety follow-up is planned 120 days after administration of the last dose of trial treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab/Nab-Paclitaxel | Experimental | Drug: Pembrolizumab, Drug: nab-paclitaxel, Drug: Epirubicin, Drug: CyclophosphamideThis is a phase II, one-arm, open label neoadjuvant study of pembrolizumab in combination with nab-paclitaxel followed by pembrolizumab in combination with epirubicin and cyclophosphamide in patients with triple negative breast cancer. All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w. After the 25th patient has started trial treatment, all further included patients will receive 1 additional cycle of pembrolizumab i.v. 200 mg q3w monotherapy before starting regular trial treatment. Clinical and bioptic tumor assessment will be performed after each treatment phase. Study treatment will be applied until state of the art surgery, onset of unacceptable toxicities, progression or withdrawal of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent prior to beginning of trial specific procedures.
- Subject must be female and aged ≥ 18 years on day of signing informed consent.
- ECOG(Eastern Cooperative Oncology Group) 0-1
- Histologically confirmed, early TNBC determined by core biopsy of breast tumor lesion. ER and PR negativity are defined as ≤ 1% of cells expressing hormonal receptors via IHC (immuno-histochemistry) analysis. HER2(human epidermal growth factor receptor 2) negativity is defined as either of the following by local laboratory assessment: In situ hybridization (ISH) non-amplified (ratio ≤ 2.2), or IHC 0 or IHC 1+.
- Measurable tumor lesion with a size of ≥ 1 cm assessed by sonography or magnetic resonance imaging (MRI) within ≤ 21 days prior to entry. In case of inflammatory disease the extent of inflammation will be measured.
Key exclusion criteria (18 listed)
- Concurrent participation in a study with an investigational agent/device or within 14 days of study entry.
- Prior chemotherapy, radiation therapy or small molecule therapy for any reason.
- Previous malignant disease being disease-free for less than 3 years (except in situ carcinoma of the cervix and basal cell carcinoma of the skin).
- Pregnancy or lactation.
- Prior therapy with an anti-PD1, anti-PD L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137).
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: Keytruda, MK-3475All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w. After the 25th patient has started trial treatment, all further included patients will receive 1 cycle of pembrolizumab i.v. 200 mg q3w monotherapy followed by 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w. | Drug | Pembrolizumab/Nab-Paclitaxel |
| nab-paclitaxelAlso: nano-particle albumin bound (NAB) paclitaxel, AbraxaneAll patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w. | Drug | Pembrolizumab/Nab-Paclitaxel |
| EpirubicinAll patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w. | Drug | Pembrolizumab/Nab-Paclitaxel |
| CyclophosphamideAll patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w. | Drug | Pembrolizumab/Nab-Paclitaxel |
Primary outcome
Pathological Complete Response (pCR) rate
Time frame: Pathological complete response will be assessed at final surgery for patients who received at least two cycles of Pembrolizumab. The rate will be assessed from 30 days until 120 days after last application of medication.
Pathological complete response (pCR) rate, defined as the complete absence of all tumor cells (ypT0/ypN0), absence of invasive tumor (ypT0/is ypN0) and regression grades after study treatment. Pathological complete response is the primary endpoint of this trial and correlates especially well with disease-free survival and overall survival in patients with TNBC. Pathological complete response also serves as a surrogate marker for prognosis in TNBC
4 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: The adverse events will be assessed from first infusion until 120 days after last application of medication.
Clinical Response
Time frame: Every 6 weeks from date of first medication administration until the date of first documented progression, surgery or date of death from any cause, whichever came first, assessed up to 120 days after last dose.
EORTC QLQ-BR23
Time frame: Every two weeks from first administration of trial medication through study completion, up to 120 days after administration of last medication.
EORTC QLQ-C30
Time frame: Every two weeks from first administration of trial medication through study completion, up to 120 days after administration of last medication.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- 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.
Peter A Fasching, MD, Prof. study chair
Department of Gynecology and Obstetrics, Erlangen University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, nab-paclitaxel and Epirubicin in people with Malignant Neoplasm of Breast, run by Institut fuer Frauengesundheit at 4 sites in Germany.
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 12 inclusion and 18 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: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pathological Complete Response (pCR) rate (time frame: Pathological complete response will be assessed at final surgery for patients who received at least two cycles of Pembrolizumab. The rate will be assessed from 30 days until 120 days after last application of medication.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2021.