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Breast CancerPhase 2TELESCOPENCT06604858

Neoadjuvant Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer

A Phase 2 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Breast Cancer and Triple Negative Breast Cancer, run by MedSIR at 11 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single arm, proof of concept phase II clinical trial to evaluate the combination of Pembrolizumab and Carboplatin plus Paclitaxel in patients with localized TNBC (tumor size ≥ 10 mm and ≤ 20 mm by mammogram and/or ultrasound, and/or ≥ 10 mm and ≤ 25 mm by breast MRI if performed within 2 weeks after biopsy… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Triple Negative Breast Cancer
What is being tested?
Pembrolizumab, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
11 sitesSpain
Study dates
29 May 2025to 7 Jul 2026
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent form (ICF) prior to beginning specific protocol procedures.
  • Female or male patients ≥ 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Histologically confirmed TNBC as defined by the most ASCO/CAP guidelines based on local laboratory results.
  • Note: TNBC means tumors that have <1 percent expression of Estrogen Receptor (ER) and Progesterone Receptor (PR) as determined by immunohistochemistry (IHC), and that are, for HER2, either 0 to 1+ by IHC, or IHC 2+ and fluorescence in situ hybridization (FISH) negative.
  • Tumor size between ≥ 10 mm and ≤ 20 mm by mammogram and/or breast ultrasound, and/or ≥ 10 mm and ≤ 25 mm after biopsy by breast magnetic resonance imaging [MRI] as per local assessment.
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  • Note: Up to 25 mm of diameter using breast MRI is allowed if the MRI was performed within 2 weeks after the breast biopsy (due to tissue inflamation after the procedure).
  • Node-negative status by clinical exam and local radiological evaluation.
  • Bilateral tumors and/or multi-focal (e.g, 2, separate lesions in the same quadrant)/multi-centric (e.g, 2 separate lesions in different quadrants) tumors are allowed. The tumor with the most advanced T stage should be used to assess the eligibility and TNBC needs to be confirmed for each breast/focus. In these cases, both axillae need to be assessed for nodal involvement confirmation.
  • No evidence of metastatic disease based on radiological assessment according to institutional practices.
  • No previous definitive ipsilateral breast surgery for the current breast cancer.
  • No prior chemotherapy, targeted therapy, and/or radiation therapy with therapeutic intent for this cancer.
  • Willingness to provide tumor tissue at baseline and at surgery and blood samples at the time of study entry (the closest time to the tumor biopsy), at C3D1, and at the end of treatment, prior to surgery (the closest time to the tumor biopsy).
  • Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test and be willing to use an adequate method of contraception according to study protocol during treatment and for at least 4 months after the last dose of pembrolizumab. Female patients must refrain from egg cell donation and breastfeeding during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab.
  • Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use institution specified method(s) of contraception and must refrain from donating sperm or eggs during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab.
  • Patient has adequate bone marrow, liver, and renal function:
  • Hematological: White blood cell (WBC) count > 3.0 x 10 9/L, absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L, platelet count ≥ 100.0 x10 9/L, and hemoglobin ≥ 9.0 g/dL (≥ 5.6 mmol/L).
  • Hepatic: total bilirubin ≤ institutional upper limit of normal (ULN) (except for Gilbert's syndrome); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN.
  • Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  • Patient must be accessible for treatment and follow-up.

Who cannot join

  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
  • Has received prior systemic anti-breast cancer therapy, including an investigational agents or has used an investigational device within 4 weeks prior to allocation.
  • Has received prior taxane or platinum-based therapy.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Has had an allogenic tissue/solid organ transplant.
  • Has a history of invasive malignancy within the last 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.
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  • Participation in an interventional clinical study within 4 weeks of first dose of study treatment.
  • Major surgical procedure or significant traumatic injury within 14 days prior to enrolment or anticipation of need for major surgery within the course of the study treatment.
  • Has received a live vaccine within 30 days of first dose of study treatment.
  • Active autoimmune disease that has required systemic treatment in past 2 years, or ANY diagnosis of immunodeficiency or is receiving systemic steroid therapy (e.g, dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Replacement therapy (e.g, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Current known infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Other active uncontrolled infection at the time of enrollment.
  • Significant cardiovascular disease within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation.
  • Pregnancy or breastfeeding or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.
  • Known hypersensitivity to the components of the study or its analogs.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Spain11 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña

  • Hospital Universitari Dexeus

    Barcelona

  • Hospital Universitari Vall D'Hebron

    Barcelona

  • Institut Català d' Oncologia Girona (ICO)

    Girona

  • Hospital Universitario Clínico San Cecilio de Granada

    Granada

  • Hospital Beata María Ana

    Madrid

  • Hospital Cínico San Carlos

    Madrid

  • Hospital Universitario de Navarra

    Pamplona

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Arnau de Vilanova de Valencia

    Valencia

Other trials in Spain

About this study

Official title: Neoadjuvant Phase II Study of Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer (The TELESCOPE Study)

This is a single arm, proof of concept phase II clinical trial to evaluate the combination of Pembrolizumab and Carboplatin plus Paclitaxel in patients with localized TNBC (tumor size ≥ 10 mm and ≤ 20 mm by mammogram and/or ultrasound, and/or ≥ 10 mm and ≤ 25 mm by breast MRI if performed within 2 weeks after biopsy, considering possible tissue inflammation post-procedure, as per local assessment), node-negative status (by clinical exam and local radiological evaluation) and who have not previously received chemotherapy, targeted therapy, and/or radiotherapy for invasive breast cancer.

Read the detailed description

After signing informed consent form (ICF) and confirmed eligibility, eligible patients with localized TNBC, node-negative status, and who have not previously received chemotherapy, targeted therapy, and/or radiotherapy for invasive breast cancer (N=30) will receive treatment with Pembrolizumab and Carboplatin plus Paclitaxel up to surgery as indicated below:

  • Pembrolizumab: 200 mg, every three weeks (Q3W), intravenously (IV) on day 1 (D1) of each cycle.
  • Carboplatin: area under the curve (AUC) 1.5 (maximum dose of 225 mg), IV on D1, D8 and D15 of each 21-days cycle.
  • Paclitaxel: 80 mg/m2, IV on D1, D8 and D15 of each 21-days cycle.

The treatment is composed by 4 cycles of 21 days each (patients will be treated for a total of 84 days) and treatment will last until surgery.

After treatment discontinuation (EoT), all patients will have a safety visit scheduled 28 days (± 7 days) after the last dose of study treatment, in order to follow up toxicities and changes in concomitant medication. Patients discontinuing the study treatment period will enter a post-treatment follow-up period during which survival and new anti-cancer therapy information will be collected every 12 weeks (± 7 days) after the safety visit until death, lost to follow-up, elective withdrawal from the study, or end of study (EoS), whichever occurs first.

Keywords
Breast Cancer, Stage I Triple Negative Breast Cancer, Pembrolizumab, Carboplatin, Paclitaxel
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

    Pembrolizumab 200 mg administered every three weeks intravenously on day 1 of each cycle.

  • CarboplatinDrug

    Carboplatin: area under the curve (AUC) of 1.5 mg/mL x min (maximum dose of 225 mg), intravenously on day 1, day 8 and day 15 of each 21-days cycle.

  • PaclitaxelDrug

    Paclitaxel: 80 mg/m2, intravenously on day 1, day 8 and day 15 of each 21-days cycle.

Study groups in NCT06604858
Study groupRoleWhat they receive
Pembrolizumab and Carboplatin plus PaclitaxelExperimentalPatients will receive treatment with Pembrolizumab and Carboplatin plus Paclitaxel up to surgery. The treatment is composed by 4 cycles of 21 days each (patients will be treated for a total of 84 days) and treatment will last until surgery.
Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

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

  1. To assess pathological complete response (pCR) rate in all patients.

    To evaluate the pCR rate defined as the percentage of patients with ypT0/is, ypN0 at surgery based on local assessment.

    The efficacy will be evaluated by pCR rates concerning breast and lymph nodes (pCR breast + lymph node) in the overall population.

    Measured: From baseline up to 84 days (the date of breast surgery).

Secondary outcomes (3)

  1. To assess pathological complete response (pCR) rate according to PD-L1 status.

    pCR rates will be calculated concerning breast and lymph nodes (pCR breast + lymph node) in patients with PD-L1 (+) tumors.

    Measured: From baseline up to 84 days (the date of breast surgery).

  2. To evaluate residual cancer burden (RCB) at surgery.

    RCB score is a numeric index with numerical cutoffs to define the four classes (RCB-0: No carcinoma in breast or axillary lymph nodes; RCB-1; RCB-2; and RCB-3). RCB score will be calculated in the overall population at surgery.

    Measured: At breast surgery.

  3. To evaluate the incidence of adverse events [Safety and Tolerability].

    Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) based on local Investigator assessment as per NCI-CTCAE v5.0.

    Measured: From baseline up to 84 days (the date of breast surgery).

Timeline

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

  1. First posted20 Sep 2024
  2. Study start29 May 2025
  3. Primary completion7 Jul 2026
  4. Study completion7 Jul 2026

Resources

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
Model description
Multicenter, single arm, non-comparative, phase II clinical trial.
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06604858
Sponsor's protocol ID
MedOPP599
Other IDs
2024-513511-27-00
Acronym
TELESCOPE
Status last verified
Jul 2026
First submitted
17 Sep 2024
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Breast Cancer and Triple Negative Breast Cancer, run by MedSIR at 11 sites in Spain.

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 20 inclusion and 17 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain. 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?

To assess pathological complete response (pCR) rate in all patients. (time frame: From baseline up to 84 days (the date of breast surgery).). 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 NCT06604858.

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 27 Jul 2026.

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