Hormone Receptor-Positive, HER2-Negative, Node Positive Breast CancerPhase 2NELOPHERNCT07394946
Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node Positive, Early-Stage Breast Cancer.
A Phase 2 study testing Letrozole in people with Hormone Receptor-Positive, HER2-Negative, Node Positive Breast Cancer, run by Cancer Care Hospital & Research Centre Foundation, Lahore at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn whether letrozole, a hormone therapy drug, is effective in treating early-stage, hormone receptor-positive, HER2-negative breast cancer that has spread to nearby lymph nodes in postmenopausal women. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Hormone Receptor-Positive, HER2-Negative, Node Positive Breast Cancer
- What is being tested?
- Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2026to Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Patients aged 18 to 69 years.
- Menopausal Status: All patients must be postmenopausal, confirmed by serum estradiol levels or other clinical criteria.
- Diagnosis: Histologically confirmed infiltrating ductal carcinoma of any grade.
- Tumor Size: Primary tumor (T) category of T1 or T2 according to AJCC 8th edition, as measured by ultrasonography (USG) and mammography.
- Node Involvement: N1 disease documented by clinical examination and USG, with histopathology confirmed by fine-needle aspiration cytology (FNAC) or core needle biopsy.
- Hormone Receptor Status: Patients must be estrogen receptor (ER) positive and progesterone receptor (PR) positive/negative, with HER2 status negative.
Who cannot join
- Age: Patients aged under 18 or over 69 years.
- Tumor Size: Patients with a primary tumor larger than T2 >5cm or with N2 disease.
- Histological Type: Infiltrating lobular carcinoma or other non-invasive breast cancer types.
- Prior Treatments: Previous treatment with neoadjuvant endocrine therapy (NET) or neoadjuvant chemotherapy (NACT).
- Comorbidities: Significant comorbidities that preclude administration of anesthesia or compromise patient safety.
- Disease Characteristics: Patients with multicentric or multifocal disease, as defined by imaging or histopathological findings.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Cancer Care Hospital and Research Centre Foundation
Lahore, Punjab Province, 54000
About this study
Official title: Neo-Adjuvant Endocrine Therapy in Post-Menopausal Hormone Receptor Positive HER 2 Neu Negative Node Positive Early-Stage Breast Cancer Patients With One Year of Letrozole.
The goal of this clinical trial is to learn whether letrozole, a hormone therapy drug, is effective in treating early-stage, hormone receptor-positive, HER2-negative breast cancer that has spread to nearby lymph nodes in postmenopausal women. The study will also evaluate the safety of taking letrozole for one year before surgery.
The main questions this study aims to answer are:
Read more
Can one year of letrozole eliminate cancer from the underarm (axillary) lymph nodes?
Can treatment with letrozole reduce the need for extensive lymph node surgery?
How safe and tolerable is long-term letrozole treatment?
This is a single-arm study, meaning all participants will receive letrozole. There is no placebo or comparison group.
Participants will:
Take letrozole 2.5 mg by mouth once daily for one year
Attend regular clinic visits for physical exams, blood tests, and imaging studies
Undergo surgery after completing treatment
Be followed for up to two years to monitor cancer recurrence and survival
Read the detailed description
What is this study about?
This clinical trial is studying the use of letrozole, a hormone therapy medicine, in postmenopausal women with early-stage breast cancer that:
- Has spread to nearby lymph nodes,
- Is hormone receptor-positive (ER and/or PR positive), and
- Is HER2-negative. Letrozole is already widely used to treat hormone-positive breast cancer. In this study, it is given before surgery for a longer period than usual (one year) to see how well it works in shrinking cancer in the underarm (axillary) lymph nodes.
Why is this study being done? Many women with breast cancer that has spread to lymph nodes need axillary lymph node dissection (ALND), a surgery that removes many lymph nodes and can cause long-term side effects such as arm swelling (lymphedema), pain, and reduced arm movement.
This study aims to find out whether one year of letrozole treatment before surgery can:
- Eliminate cancer from the lymph nodes in some patients, and
- Reduce or avoid the need for extensive lymph node surgery.
Who can take part in this study?
Participants must:
- Be postmenopausal women aged 18-69 years,
- Have early-stage breast cancer (tumor size T1-T2),
- Have cancer in nearby lymph nodes (N1),
- Have hormone receptor-positive, HER2-negative breast cancer,
- Not have received prior chemotherapy or hormone therapy for this cancer. What treatment will participants receive?
All participants will receive:
- Letrozole 2.5 mg, taken once daily by mouth,
- For a total duration of one year before surgery. There is no placebo and no comparison group in this study.
What will happen during the study?
- Screening and Baseline
- Medical history, physical examination
- Blood tests and breast/axillary imaging (ultrasound, mammography)
- Confirmation of eligibility
- Treatment Phase (1 year)
- Daily oral letrozole
- Regular follow-up visits for: Clinical assessments Imaging of lymph nodes Monitoring side effects
- Surgery and Follow-up
- Surgical evaluation of lymph nodes
- Pathology testing to see if cancer remains
- Follow-up for up to two years to monitor recurrence and survival
What are the main goals of the study? Primary goal
- To determine how many patients have no remaining cancer in the axillary lymph nodes (pathological complete response) after one year of letrozole treatment.
- To assess whether lymph node shrinkage may allow patients to avoid axillary lymph node dissection.
Secondary goals
- To measure:
- Local or regional cancer recurrence,
- Spread of cancer to distant organs,
- Overall survival and disease-free survival,
- Safety and side effects of long-term letrozole use.
- To evaluate how well ultrasound imaging predicts lymph node response to treatment.
How many participants will be included? A total of 126 patients will take part in this study.
Why is this study important?
If successful, this study may:
- Reduce the need for extensive lymph node surgery,
- Lower the risk of long-term surgical complications,
- Support a less invasive treatment approach for selected patients with hormone-positive breast cancer.
The results could help improve future treatment strategies for postmenopausal women with early-stage, node-positive breast cancer.
- Being tested
- Letrozole
- Keywords
- Early-Stage Breast Cancer, HER2-Negative Breast Cancer, Node-Positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Letrozole, Oral, 2.5mg daily, for 1 year
Letrozole is an oral aromatase inhibitor administered at a dose of 2.5 mg once daily for one year. It is used as neoadjuvant therapy in postmenopausal women with early-stage, hormone receptor-positive (ER+/PR+), HER2-negative, node-positive breast cancer to reduce tumor size and axillary lymph node involvement before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | Letrozole, Oral, 2.5mg daily, for 1 year Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of Axillary Nodal Pathologic Complete Response (pCR)
Proportion of postmenopausal, hormone receptor-positive (ER+/PR+), HER2-negative, node-positive breast cancer patients achieving pathological complete response (pCR) in axillary lymph nodes after one year of neoadjuvant letrozole therapy, assessed by sentinel lymph node biopsy (SLNBx).
Measured: From baseline (pre-treatment) to the end of one-year letrozole treatment
Secondary outcomes (3)
Loco-Regional Relapse Rate
Proportion of patients experiencing loco-regional recurrence (breast, chest wall, or axillary nodes) following one year of neoadjuvant letrozole therapy.
Measured: Assessed at 6, 12, and 24 months post-treatment initiation
Distant Relapse Rate
Proportion of patients developing distant metastases (e.g., bone, liver, lungs) after one year of neoadjuvant letrozole therapy.
Measured: Assessed at 6, 12, and 24 months post-treatment initiation
Safety and Tolerability
Frequency and severity of adverse events reported by participants or observed by investigators during letrozole therapy, categorized according to CTCAE v5.0.
Measured: Monitored continuously during the 1-year treatment period, reported at 3-month intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor-Positive, HER2-Negative, Node Positive 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same intervention - letrozole 2.5 mg orally daily for one year - and outcomes will be measured within this single group. There is no randomization, control, or comparator group, making it a single-arm study.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Care Hospital & Research Centre Foundation, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394946
- Sponsor's protocol ID
- CCH-001
- Acronym
- NELOPHER
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to patient privacy and institutional data protection policies. Aggregate study results will be made publicly available through ClinicalTrials.gov and peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo-Adjuvant Endocrine Therapy in Post-Menopausal Hormone Receptor Positive HER 2 Neu Negative Node Positive Early-Stage Breast Cancer Patients With One Year of Letrozole.
- ClinicalTrials.gov ID
- NCT07394946
- Acronym / sponsor ID
- NELOPHER / CCH-001
- Keywords
- Early-Stage Breast Cancer, HER2-Negative Breast Cancer, Node-Positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Cancer Care Hospital & Research Centre Foundation, LahoreUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 6 Feb 2026 (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.
The goal of this clinical trial is to learn whether letrozole, a hormone therapy drug, is effective in treating early-stage, hormone receptor-positive, HER2-negative breast cancer that has spread to nearby lymph nodes in postmenopausal women. The study will also evaluate the safety of taking letrozole for one year before surgery.
The main questions this study aims to answer are:
Can one year of letrozole eliminate cancer from the underarm (axillary) lymph nodes?
Can treatment with letrozole reduce the need for extensive lymph node surgery?
How safe and tolerable is long-term letrozole treatment?
This is a single-arm study, meaning all participants will receive letrozole. There is no placebo or comparison group.
Participants will:
Take letrozole 2.5 mg by mouth once daily for one year
Attend regular clinic visits for physical exams, blood tests, and imaging studies
Undergo surgery after completing treatment
Be followed for up to two years to monitor cancer recurrence and survival
Detailed description
What is this study about?
This clinical trial is studying the use of letrozole, a hormone therapy medicine, in postmenopausal women with early-stage breast cancer that:
- Has spread to nearby lymph nodes,
- Is hormone receptor-positive (ER and/or PR positive), and
- Is HER2-negative. Letrozole is already widely used to treat hormone-positive breast cancer. In this study, it is given before surgery for a longer period than usual (one year) to see how well it works in shrinking cancer in the underarm (axillary) lymph nodes.
Why is this study being done? Many women with breast cancer that has spread to lymph nodes need axillary lymph node dissection (ALND), a surgery that removes many lymph nodes and can cause long-term side effects such as arm swelling (lymphedema), pain, and reduced arm movement.
This study aims to find out whether one year of letrozole treatment before surgery can:
- Eliminate cancer from the lymph nodes in some patients, and
- Reduce or avoid the need for extensive lymph node surgery.
Who can take part in this study?
Participants must:
- Be postmenopausal women aged 18-69 years,
- Have early-stage breast cancer (tumor size T1-T2),
- Have cancer in nearby lymph nodes (N1),
- Have hormone receptor-positive, HER2-negative breast cancer,
- Not have received prior chemotherapy or hormone therapy for this cancer. What treatment will participants receive?
All participants will receive:
- Letrozole 2.5 mg, taken once daily by mouth,
- For a total duration of one year before surgery. There is no placebo and no comparison group in this study.
What will happen during the study?
- Screening and Baseline
- Medical history, physical examination
- Blood tests and breast/axillary imaging (ultrasound, mammography)
- Confirmation of eligibility
- Treatment Phase (1 year)
- Daily oral letrozole
- Regular follow-up visits for: Clinical assessments Imaging of lymph nodes Monitoring side effects
- Surgery and Follow-up
- Surgical evaluation of lymph nodes
- Pathology testing to see if cancer remains
- Follow-up for up to two years to monitor recurrence and survival
What are the main goals of the study? Primary goal
- To determine how many patients have no remaining cancer in the axillary lymph nodes (pathological complete response) after one year of letrozole treatment.
- To assess whether lymph node shrinkage may allow patients to avoid axillary lymph node dissection.
Secondary goals
- To measure:
- Local or regional cancer recurrence,
- Spread of cancer to distant organs,
- Overall survival and disease-free survival,
- Safety and side effects of long-term letrozole use.
- To evaluate how well ultrasound imaging predicts lymph node response to treatment.
How many participants will be included? A total of 126 patients will take part in this study.
Why is this study important?
If successful, this study may:
- Reduce the need for extensive lymph node surgery,
- Lower the risk of long-term surgical complications,
- Support a less invasive treatment approach for selected patients with hormone-positive breast cancer.
The results could help improve future treatment strategies for postmenopausal women with early-stage, node-positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same intervention - letrozole 2.5 mg orally daily for one year - and outcomes will be measured within this single group. There is no randomization, control, or comparator group, making it a single-arm study.
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: LetrozoleLetrozole, Oral, 2.5mg daily, for 1 year |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: Patients aged 18 to 69 years.
- Menopausal Status: All patients must be postmenopausal, confirmed by serum estradiol levels or other clinical criteria.
- Diagnosis: Histologically confirmed infiltrating ductal carcinoma of any grade.
- Tumor Size: Primary tumor (T) category of T1 or T2 according to AJCC 8th edition, as measured by ultrasonography (USG) and mammography.
- Node Involvement: N1 disease documented by clinical examination and USG, with histopathology confirmed by fine-needle aspiration cytology (FNAC) or core needle biopsy.
Key exclusion criteria (6 listed)
- Age: Patients aged under 18 or over 69 years.
- Tumor Size: Patients with a primary tumor larger than T2 >5cm or with N2 disease.
- Histological Type: Infiltrating lobular carcinoma or other non-invasive breast cancer types.
- Prior Treatments: Previous treatment with neoadjuvant endocrine therapy (NET) or neoadjuvant chemotherapy (NACT).
- Comorbidities: Significant comorbidities that preclude administration of anesthesia or compromise patient safety.
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 |
|---|---|---|
| LetrozoleAlso: Letrozole, Oral, 2.5mg daily, for 1 yearLetrozole is an oral aromatase inhibitor administered at a dose of 2.5 mg once daily for one year. It is used as neoadjuvant therapy in postmenopausal women with early-stage, hormone receptor-positive (ER+/PR+), HER2-negative, node-positive breast cancer to reduce tumor size and axillary lymph node involvement before surgery. | Drug | Letrozole |
Primary outcome
Extent of Axillary Nodal Pathologic Complete Response (pCR)
Time frame: From baseline (pre-treatment) to the end of one-year letrozole treatment
Proportion of postmenopausal, hormone receptor-positive (ER+/PR+), HER2-negative, node-positive breast cancer patients achieving pathological complete response (pCR) in axillary lymph nodes after one year of neoadjuvant letrozole therapy, assessed by sentinel lymph node biopsy (SLNBx).
3 secondary outcomes
Loco-Regional Relapse Rate
Time frame: Assessed at 6, 12, and 24 months post-treatment initiation
Distant Relapse Rate
Time frame: Assessed at 6, 12, and 24 months post-treatment initiation
Safety and Tolerability
Time frame: Monitored continuously during the 1-year treatment period, reported at 3-month intervals.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to patient privacy and institutional data protection policies. Aggregate study results will be made publicly available through ClinicalTrials.gov and peer-reviewed publications.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole in people with Hormone Receptor-Positive, HER2-Negative, Node Positive Breast Cancer, run by Cancer Care Hospital & Research Centre Foundation, Lahore at 1 site in Pakistan.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Eram Akram (+923365163135, umemustafa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of Axillary Nodal Pathologic Complete Response (pCR) (time frame: From baseline (pre-treatment) to the end of one-year letrozole treatment). 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 20 Feb 2026.